Trial Outcomes & Findings for A Pilot Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope (NCT NCT02122796)
NCT ID: NCT02122796
Last Updated: 2018-04-02
Results Overview
Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.
COMPLETED
NA
30 participants
One year
2018-04-02
Participant Flow
Participant milestones
| Measure |
Acupuncture
Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.
Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body.
|
Standard of Care
Standard of care post-mastectomy.
|
|---|---|---|
|
Visit 1
STARTED
|
15
|
15
|
|
Visit 1
COMPLETED
|
15
|
15
|
|
Visit 1
NOT COMPLETED
|
0
|
0
|
|
Visit 2
STARTED
|
15
|
15
|
|
Visit 2
COMPLETED
|
12
|
14
|
|
Visit 2
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope
Baseline characteristics by cohort
| Measure |
Acupuncture
n=15 Participants
Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.
Acupuncture: Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body.
|
Standard of Care
n=15 Participants
Standard of care post-mastectomy.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.74 years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
62.47 years
STANDARD_DEVIATION 11.47 • n=7 Participants
|
57.52 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
<9th Grade
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Education
9th to 12th Grade
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Education
High School Graduate
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Education
Some College or Associate Degree
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Education
Bachelor's Degree or Higher
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Employment Status
Full-time
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Employment Status
Part-time
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Employment Status
Homemaker
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Employment Status
Retired
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Employment Status
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Family Income
<$24,999
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Family Income
$25,000-39,999
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Family Income
$40,000-54,999
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Family Income
$55,000-74,999
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Family Income
$75,000 or more
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Family Income
Unknown
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Marital Status
Married
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Marital Status
Living in marriage-like relationship
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Marital Status
Divorced/separated
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Marital Status
Widowed
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Marital Status
Never married
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: A total of 252 women were scheduled to receive a unilateral or bilateral mastectomy during the study period. Of those, 61 were eligible for study participation, and there were 30 women who provided consent and were randomized.
Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.
Outcome measures
| Measure |
Patients Undergoing Mastectomy Surgery
n=252 Participants
Number of individuals having mastectomy surgery who were approached for participation in the trial
|
Standard of Care
Standard of care post-mastectomy.
|
|---|---|---|
|
Number of Patients Eligible Compared to the Number Approached and Enrolled
Elligible
|
61 Participants
|
—
|
|
Number of Patients Eligible Compared to the Number Approached and Enrolled
Approached
|
252 Participants
|
—
|
|
Number of Patients Eligible Compared to the Number Approached and Enrolled
Consented
|
30 Participants
|
—
|
|
Number of Patients Eligible Compared to the Number Approached and Enrolled
Declined
|
31 Participants
|
—
|
|
Number of Patients Eligible Compared to the Number Approached and Enrolled
Final Sample with complete data
|
26 Participants
|
—
|
SECONDARY outcome
Timeframe: Participants will be followed on post operations day 1 and 2 of their hospital stayChange in pain on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no pain and 10 equals most severe pain. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Pain Day 1 - Pre-Pain Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
Outcome measures
| Measure |
Patients Undergoing Mastectomy Surgery
n=12 Participants
Number of individuals having mastectomy surgery who were approached for participation in the trial
|
Standard of Care
n=14 Participants
Standard of care post-mastectomy.
|
|---|---|---|
|
Change in Pain Post Intervention
Visit 1 Mean Change in Pain
|
-1.47 units on a scale
Standard Deviation 1.06
|
-0.07 units on a scale
Standard Deviation 1.67
|
|
Change in Pain Post Intervention
Visit 2 Mean Change in Pain
|
-1.50 units on a scale
Standard Deviation 0.97
|
-0.43 units on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Participants will be followed on post operations day 1 and 2 of their hospital stayChange in anxiety on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no anxiety and 10 equals most severe anxiety. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Anxiety Day 1 - Pre-Anxiety Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
Outcome measures
| Measure |
Patients Undergoing Mastectomy Surgery
n=12 Participants
Number of individuals having mastectomy surgery who were approached for participation in the trial
|
Standard of Care
n=14 Participants
Standard of care post-mastectomy.
|
|---|---|---|
|
Change in Anxiety Post Intervention
Visit 1 Change in Anxiety
|
-1.33 units on a scale
Standard Deviation 1.59
|
0.53 units on a scale
Standard Deviation 2.88
|
|
Change in Anxiety Post Intervention
Visit 2 Change in Anxiety
|
-0.90 units on a scale
Standard Deviation 1.45
|
0.14 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Participants will be followed on post operations day 1 and 2 of their hospital stayChange in nausea on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no nausea and 10 equals most severe nausea. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Nausea Day 1 - Pre-Nausea Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
Outcome measures
| Measure |
Patients Undergoing Mastectomy Surgery
n=12 Participants
Number of individuals having mastectomy surgery who were approached for participation in the trial
|
Standard of Care
n=14 Participants
Standard of care post-mastectomy.
|
|---|---|---|
|
Change in Nausea Post Intervention
Visit 1 Change in Nausea
|
-1.53 units on a scale
Standard Deviation 2.70
|
0.73 units on a scale
Standard Deviation 1.75
|
|
Change in Nausea Post Intervention
Visit 2 Change in Nausea
|
-0.50 units on a scale
Standard Deviation 1.27
|
-0.29 units on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Participants will be followed on post operations day 1 and 2 of their hospital stayChange in ability to cope on a single question 11-point Numeric Rating Scale (NRS) where 0 equals absence of an ability to cope and 10 equals complete ability to cope. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Coping Day 1 - Pre-Coping Day 1). . A higher score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.
Outcome measures
| Measure |
Patients Undergoing Mastectomy Surgery
n=12 Participants
Number of individuals having mastectomy surgery who were approached for participation in the trial
|
Standard of Care
n=14 Participants
Standard of care post-mastectomy.
|
|---|---|---|
|
Change in Ability to Cope Post Intervention
Visit 1 Change in Ability to Cope
|
1.87 units on a scale
Standard Deviation 2.97
|
-0.47 units on a scale
Standard Deviation 1.36
|
|
Change in Ability to Cope Post Intervention
Visit 2 Change in Ability to Cope
|
0.30 units on a scale
Standard Deviation 3.06
|
0.07 units on a scale
Standard Deviation 0.47
|
Adverse Events
Acupuncture
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Integrative Health Reseach Center
Allina Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place