Trial Outcomes & Findings for Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients (NCT NCT05711537)
NCT ID: NCT05711537
Last Updated: 2024-06-25
Results Overview
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
COMPLETED
NA
21 participants
Baseline
2024-06-25
Participant Flow
Participant milestones
| Measure |
Intervention Auricular Acupressure (AA) Group
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
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|---|---|
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Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
18
|
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Overall Study
NOT COMPLETED
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3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
Baseline characteristics by cohort
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineIn a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Pain Scores Using Numerical Rating Scale (NRS)
|
6.62 score on a scale
Standard Deviation 1.36
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: 1 subject withdrew participation
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=20 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Pain Scores Using Numerical Rating Scale (NRS)
|
7 score on a scale
Standard Deviation 1.86
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2Population: 1 subject withdrew after baseline
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=20 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Pain Scores Using Numerical Rating Scale (NRS)
|
7.2 score on a scale
Standard Deviation 2.22
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3Population: 1 subject withdrew after baseline and 2 were discharged home on day 2
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Pain Scores Using Numerical Rating Scale (NRS)
|
6.68 score on a scale
Standard Deviation 2.26
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePatient reported assessment of pain intensity and interference. We will compare scores before and after initiation of Auricular Acupressure. The PEG scale consists of 3 separate numerical scales: PEG-1 What number best describes your pain this week?, PEG-2 What number describes how during the past week pain has interfered with your enjoyment of life?, and PEG-3 What number best describes how during the past week pain has interfered with your general activity? Each scale has ratings ranging from 0-10. Individuals rate their pain level concerning 3 different areas. Higher scores represent more pain and or increased enjoyment and activity interference.
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
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|---|---|---|---|---|
|
Pain, Enjoyment and General Activity (PEG) Assessment Scores
PEG-1
|
7 score on a scale
Standard Deviation 1.76
|
—
|
—
|
—
|
|
Pain, Enjoyment and General Activity (PEG) Assessment Scores
PEG-2
|
7.57 score on a scale
Standard Deviation 2.36
|
—
|
—
|
—
|
|
Pain, Enjoyment and General Activity (PEG) Assessment Scores
PEG-3
|
7.71 score on a scale
Standard Deviation 2.45
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3Population: 1 withdrew study participation after day 1 and 2 were discharged home
Patient reported assessment of pain intensity and interference. We will compare scores before and after initiation of Auricular Acupressure. The PEG scale consists of 3 separate numerical scales: PEG-1 What number best describes your pain this week?, PEG-2 What number describes how during the past week pain has interfered with your enjoyment of life?, and PEG-3 What number best describes how during the past week pain has interfered with your general activity? Each scale has ratings ranging from 0-10. Individuals rate their pain level concerning 3 different areas. Higher scores represent more pain and or increased enjoyment and activity interference.
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Pain, Enjoyment and General Activity (PEG) Assessment Scores
PEG-1
|
6.5 score on a scale
Standard Deviation 1.86
|
—
|
—
|
—
|
|
Pain, Enjoyment and General Activity (PEG) Assessment Scores
PEG-2
|
5.89 score on a scale
Standard Deviation 3.03
|
—
|
—
|
—
|
|
Pain, Enjoyment and General Activity (PEG) Assessment Scores
PEG-3
|
6.44 score on a scale
Standard Deviation 3.22
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineScores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
|
65.85 score on a scale
Standard Deviation 17.71
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
|
65.42 score on a scale
Standard Deviation 28.08
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
|
70.10 score on a scale
Standard Deviation 25.91
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3Scores range from 0-100. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
|
70.05 score on a scale
Standard Deviation 29.31
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, and Day 3Population: morphine mg equivalents (MME) total excluding buprenorphine
Pre-Admission Opioid requirement and change from baseline (medication used during the intervention and as reported afterwards vs. home dose before the study started) collecting type, frequency and milligram use and date and time of last use prior to admission measuring mean/median changes from Baseline to Day 3 post evaluation.
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
n=20 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
n=20 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Changes in Amount of Opioid Use
|
84.95 morphine mg equivalents
Standard Error 46.14
|
67.34 morphine mg equivalents
Standard Error 19.88
|
71.01 morphine mg equivalents
Standard Error 22.62
|
53.16 morphine mg equivalents
Standard Error 19.14
|
SECONDARY outcome
Timeframe: Day 3Population: percentage of total subjects who desire to decrease their dependency on opioids: answer as strongly disagree, neither agree or disagree, agree, or strongly agree
Assessment of patient's willingness or desire to decrease opioid dependence and usage will be assessed by asking the subject to answer (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree - A higher score denotes a greater willingness to decrease dependence.
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Willingness to Decrease Dependence Scores
|
15.79 percentage of participants
|
26.32 percentage of participants
|
21.05 percentage of participants
|
36.84 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 3Population: 17 paired assessments on Day 3
A 7 item scale to identify Generalized Anxiety Disorder symptoms of evaluation. Patients are asked to rate anxiety symptoms on a scale of 0-3. Total scores for all 7 items range from 0-21. Higher scores indicate increased severity.
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
n=17 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder (GAD-7) Score Changes
|
10.9 score on a scale
Standard Deviation 5.3
|
9.53 score on a scale
Standard Deviation 6.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 3Population: 16 paired assessments
The assessment of thoughts and feelings of the patients will be assessed using questions that are rated 0 for not at all to 4 for all the time. "The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to low back pain according to 3 components: rumination, magnification, and helplessness. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing."
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
n=17 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Pain Catastrophizing Scale (PCS) Assessments
|
23.15 score on a scale
Standard Deviation 13.83
|
24.82 score on a scale
Standard Deviation 13.39
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure) the first was a Likert scale satisfaction question. This outcome pertains only to the following acceptability question: "How satisfied were you with how your pain has been treated?" using the Likert scale to measure "Very satisfied =5, Satisfied=4, Somewhat satisfied = 3, Somewhat dissatisfied= 2, Dissatisfied 1, Very Dissatisfied 0
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=19 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Auricular Acupressure Acceptability-DAY 3-Satisfaction
Answered "Dissatisfied"
|
10.5 percentage of participants
|
—
|
—
|
—
|
|
Auricular Acupressure Acceptability-DAY 3-Satisfaction
Answered "Very Satisfied"
|
21.05 percentage of participants
|
—
|
—
|
—
|
|
Auricular Acupressure Acceptability-DAY 3-Satisfaction
Answered "Satisfied"
|
21.05 percentage of participants
|
—
|
—
|
—
|
|
Auricular Acupressure Acceptability-DAY 3-Satisfaction
Answered "Somewhat satisfied"
|
47.4 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure). The second question posed a yes/no question. This outcome pertains only to the following question: Would you consider using auricular acupressure in the future for pain or if recommended by your nurse or physician? a. No, would not use again (Score of 0) b. Maybe (Score of 1), c. Yes, I would consider using in the future (Score of 2) 3
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=19 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Auricular Acupressure Acceptability--DAY 3-future Use
Answered "No, would not use again"
|
15.8 Percentage of participants
|
—
|
—
|
—
|
|
Auricular Acupressure Acceptability--DAY 3-future Use
Answered "Maybe"
|
31.6 Percentage of participants
|
—
|
—
|
—
|
|
Auricular Acupressure Acceptability--DAY 3-future Use
Answered "Yes, would definitely consider using again"
|
52.6 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 3Patient reported assessment of improvement or decline of their pain - The patient enters his answer on a 7-point scale scored as: (1) "very much better," (2) "much better," (3) "a little better," (4) "no change," (5) "a little worse," (6) "much worse," or (7) "very much worse."
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Change in Patient Global Impression of Change (PGIC) Scores
|
3.33 score on a scale
Standard Deviation .686
|
3.22 score on a scale
Standard Deviation .878
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 3Sleep disturbance is a patient reported assessment on the quality of their sleep - Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Outcome measures
| Measure |
Intervention Auricular Acupressure (AA) Group
n=21 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 1
n=18 Participants
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 2
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
Intervention Auricular Acupressure (AA) Group-DAY 3
Participants will participate in the Auricular Acupressure intervention over 3 days in addition to the Standard of Care treatment for Chronic Pain and complete questionnaires
Auricular Acupressure with Vaccaria 600t ear seeds: Auricular Acupressure utilizing vaccaria 600 t ear seeds applied to 5 designated sites to each ear. Both ears will have seeds applied. Participants will be asked if they consent to having their intervention session photographed and audio recorded in collaboration with the BAA press training and intervention fidelity study.
|
|---|---|---|---|---|
|
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)
|
21.85 score on a scale
Standard Deviation 5.62
|
17.89 score on a scale
Standard Deviation 6.32
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3Three questions were asked to evaluate acceptance of the intervention (Auricular Acupressure). The third question was a qualitative question: "Is there anything else you would like to tell us that may be helpful for us to know regarding ear acupressure?
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1The Interventionist's (Acupressure nurse) will be asked to capture time related to completion of study tasks and other qualitative questions to assess overall feasibility.
Outcome measures
Outcome data not reported
Adverse Events
Intervention Auricular Acupressure (AA) Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place