Trial Outcomes & Findings for Nurse Initiated Acupressure for Pain Management (NCT NCT04044716)

NCT ID: NCT04044716

Last Updated: 2022-12-07

Results Overview

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). Pain score averaged across post-op days 1 - 4.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: Up to Post-operatively day 4, at rising approximately 6 am
• Results posted on: 2022-12-07

Participant Flow

Participant milestones

Measure	Auricular Acupressure Group The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Nurse Interventionists Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.
Overall Study STARTED	30	30	5
Overall Study COMPLETED	27	27	5
Overall Study NOT COMPLETED	3	3	0

Reasons for withdrawal

Measure	Auricular Acupressure Group The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Nurse Interventionists Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.
Overall Study participant stopped treatment but submitted partial data.	1	0	0
Overall Study Lost to Follow-up	2	3	0

Baseline Characteristics

Nurse Initiated Acupressure for Pain Management

Baseline characteristics by cohort

Measure	Auricular Acupressure Group n=30 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=30 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Total n=60 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 9.9 • n=5 Participants	66 years STANDARD_DEVIATION 8.3 • n=7 Participants	66 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	29 Participants n=7 Participants	58 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Post-operatively day 4, at rising approximately 6 am

Population: 1 in Treatment and 2 in Standard of Care (SOC) group with incomplete missing data.

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). Pain score averaged across post-op days 1 - 4.

Outcome measures

Measure	Auricular Acupressure Group n=26 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=25 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	3.03 units on a scale Standard Deviation 2.04	4.37 units on a scale Standard Deviation 2.18

PRIMARY outcome

Timeframe: Up to Post-operatively day 4, at the end of the day approximately 10 pm

Population: 3 in Treatment group and 3 in Standard of Care (SOC) group with missing data.

Average "pain before bed" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).Pain score averaged across post-op days 0 - 4.

Outcome measures

Measure	Auricular Acupressure Group n=24 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=24 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	5.27 units on a scale Standard Deviation 2.51	6.11 units on a scale Standard Deviation 2.21

PRIMARY outcome

Timeframe: Up to post-operatively day 4

Population: 1 in Treatment group and 1 in Standard of Care (SOC) group with missing data.

Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively

Outcome measures

Measure	Auricular Acupressure Group n=26 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=26 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Medication Use - Outpatient Opioids	74.2 morphine milligram equivalents Standard Deviation 58.9	88.6 morphine milligram equivalents Standard Deviation 73.1

PRIMARY outcome

Timeframe: Up to post-operatively day 4

Population: Data obtained from hospital medication administration record on all participants.

Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)

Outcome measures

Measure	Auricular Acupressure Group n=30 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=30 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Medication Use - Inpatient Opioids	37.8 MME Standard Deviation 28.3	35.8 MME Standard Deviation 28.6

PRIMARY outcome

Timeframe: Up to post-operatively day 4

Population: 1 in Treatment group and 3 in Standard of Care (SOC) group with missing data.

Amount of of other analgesics other than aspirin and not part of anesthesia record from immediate post-operative period to day 4 post-op in reported milligrams.

Outcome measures

Measure	Auricular Acupressure Group n=26 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=24 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Medication Use - Total Other Analgesics	13643 milligrams Standard Deviation 4615	13766 milligrams Standard Deviation 3395

SECONDARY outcome

Timeframe: Baseline

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Outcome measures

Measure	Auricular Acupressure Group n=30 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=30 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	2.30 units on a scale Standard Deviation 2.28	2.84 units on a scale Standard Deviation 2.69

SECONDARY outcome

Timeframe: post-operatively day 1, at rising

Population: Data from "other" participant in treatment group who stopped study treatment.

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Outcome measures

Measure	Auricular Acupressure Group n=28 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=27 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	3.05 units on a scale Standard Deviation 2.36	3.90 units on a scale Standard Deviation 2.52

SECONDARY outcome

Timeframe: post-operatively day 2, at rising

Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain.

Outcome measures

Measure	Auricular Acupressure Group n=27 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=27 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	3.76 units on a scale Standard Deviation 2.79	5.01 units on a scale Standard Deviation 2.70

SECONDARY outcome

Timeframe: post-operatively day 3, at rising

Population: 2 in Treatment with missing data.

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Outcome measures

Measure	Auricular Acupressure Group n=25 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=27 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	2.60 units on a scale Standard Deviation 2.02	4.46 units on a scale Standard Deviation 2.42

SECONDARY outcome

Timeframe: post-operatively day 4, at rising

Population: 2 in Treatment and 2 in Standard of Care (SOC) group with missing data.

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Outcome measures

Measure	Auricular Acupressure Group n=25 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=25 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	2.81 units on a scale Standard Deviation 2.13	4.25 units on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: post-operatively day 1, at the end of the day

Population: 1 in Standard of Care group with missing data.

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Outcome measures

Measure	Auricular Acupressure Group n=27 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=26 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	5.64 units on a scale Standard Deviation 3.11	6.46 units on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: post-operatively day 2, at the end of the day

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Outcome measures

Measure	Auricular Acupressure Group n=27 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=27 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	5.79 units on a scale Standard Deviation 2.73	6.48 units on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: post-operatively day 3, at the end of the day

Population: 2 in Treatment with missing data.

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Outcome measures

Measure	Auricular Acupressure Group n=25 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=27 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	4.78 units on a scale Standard Deviation 2.74	6.27 units on a scale Standard Deviation 2.49

SECONDARY outcome

Timeframe: post-operatively day 4, at the end of the day

Population: 3 in Treatment and 3 in Standard of Care (SOC) group with missing data.

Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

Outcome measures

Measure	Auricular Acupressure Group n=24 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=24 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Visual Analogue Pain Scale	4.47 units on a scale Standard Deviation 2.75	5.80 units on a scale Standard Deviation 2.46

SECONDARY outcome

Timeframe: Up to post-operatively day 4

Population: 3 in Treatment with missing data.

Mean number of pellets retained on post-operative day 4. This Outcome Measure was pre-specified to be assessed for the "Auricular Acupressure Group" Arm only.

Outcome measures

Measure	Auricular Acupressure Group n=10 Pellets The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Mean Number of Pellets Retained	7.38 number of pellets Standard Deviation 4.15	—

SECONDARY outcome

Timeframe: post-operatively day 4

Population: 8 in Treatment and 5 in Standard of Care (SOC) group with missing data. Results indicate number of respondents who endorsed they were satisfied (very satisfied to somewhat satisfied) with pain management.

Likert scale with a total score of 0 to 6--higher scores denotes worse outcomes. Force choice: very satisfied, satisfied, somewhat satisfied, somewhat dissatisfied, dissatisfied, very dissatisfied. Any degree of satisfaction compared to any degree of dissatisfaction. Satisfied included responses very satisfied to somewhat satisfied

Outcome measures

Measure	Auricular Acupressure Group n=19 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=22 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Number of Participants Who Responded They Were Satisfied With Pain Management	19 Participants	21 Participants

SECONDARY outcome

Timeframe: post-operatively day 4

Population: 6 in Treatment and 5 in Standard of Care (SOC) group with missing data. Results are percent of total respondents who selected: "Yes, would definitely consider using in the future."

Participants were asked if they "would consider using auricular acupressure in the future for pain if recommended by a nurse or physician?" Possible answers are "no, would not use again", "maybe", or "Yes, would definitely consider using in the future."

Outcome measures

Measure	Auricular Acupressure Group n=21 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=22 Participants Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Number of Participants Who Responded "Yes, Would Definitely Consider Using in the Future."	19 Participants	13 Participants

SECONDARY outcome

Timeframe: post-operatively day 5

Population: Data collected while inpatient on all 30 participants in treatment arm. Missing data on 2 participants. This outcome applies to the AA group only.

Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction.

Outcome measures

Measure	Auricular Acupressure Group n=28 Participants The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Nurse Time to Deploy Pellets	13.5 minutes Interval 6.0 to 18.0	—

SECONDARY outcome

Timeframe: post-operatively day 0 and 1

Review nurse reports in encounters. Count number of concerns pooled across all participants in encounters with disruption of workflow due to care unit or patient barriers documented while participant was in hospital. Concerns included workflow and patient barriers. This outcome applies to nurse interventionists arm only.

Outcome measures

Measure	Auricular Acupressure Group n=120 encounters The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Number of Nurse Concerns Reported	10 number of concerns reported	—

Adverse Events

Auricular Acupressure Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Auricular Acupressure Group n=30 participants at risk The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.	Standard of Care Group n=30 participants at risk Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician.
Skin and subcutaneous tissue disorders Irritation at auricular acupressure site	3.3% 1/30 • Number of events 2 • Adverse events collected from post-operative day 0 - post-operative day 5 self reported on daily study questionnaire; no adverse event information gathered for Nurse Interventionist arm	0.00% 0/30 • Adverse events collected from post-operative day 0 - post-operative day 5 self reported on daily study questionnaire; no adverse event information gathered for Nurse Interventionist arm

Additional Information

Dr. Carolyn Huffman

Atrium Health Wake Forest Baptist

Phone: 336.713.4018

Email: cshuffma@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place