Trial Outcomes & Findings for Battlefield Auricular Acupressure (BAApress) Feasibility Study (NCT NCT05939388)

Results Overview

Visual Analogue Scale (VAS) for Pain is marked by subject on a line that ranges from 0mm to 100mm. The study team will measure where the participant marks to the nearest mm which will provide a score. Higher scores denote higher pain with higher levels of activity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Baseline

Results posted on

2025-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Auricular Acupressure Pad Group All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Auricular Acupressure Pad Group All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Battlefield Auricular Acupressure (BAApress) Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Age, Continuous	49.64 years STANDARD_DEVIATION 14.88 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	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	5 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Visual Analogue Scale (VAS) for Pain is marked by subject on a line that ranges from 0mm to 100mm. The study team will measure where the participant marks to the nearest mm which will provide a score. Higher scores denote higher pain with higher levels of activity.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Patient Reported Pain and General Activity Scores (Visual Analogue Scale)	65 mm Interval 51.8 to 78.2

PRIMARY outcome

Timeframe: Day 1

Visual Analogue Scale (VAS) for Pain is marked by subject on a line that ranges from 0mm to 100mm. The study team will measure where the participant marks to the nearest mm which will provide a score. Higher scores denote higher pain with higher levels of activity.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Patient Reported Pain and General Activity Scores (Visual Analogue Scale)	57.3 mm Interval 41.0 to 73.5

PRIMARY outcome

Timeframe: Day 2

Visual Analogue Scale (VAS) for Pain is marked by subject on a line that ranges from 0mm to 100mm. The study team will measure where the participant marks to the nearest mm which will provide a score. Higher scores denote higher pain with higher levels of activity.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Patient Reported Pain and General Activity Scores (Visual Analogue Scale)	52.7 mm Interval 33.3 to 72.1

PRIMARY outcome

Timeframe: Day 3

Visual Analogue Scale (VAS) for Pain is marked by subject on a line that ranges from 0mm to 100mm. The study team will measure where the participant marks to the nearest mm which will provide a score. Higher scores denote higher pain with higher levels of activity.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=10 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Patient Reported Pain and General Activity Scores (Visual Analogue Scale)	42.2 mm Interval 19.3 to 65.1

PRIMARY outcome

Timeframe: Day 1

Average milligram per day of a non-opioid analgesic.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Pain Medication Usage	291 milligrams Interval 16.0 to 566.0

PRIMARY outcome

Timeframe: Day 2

Average milligram per day of a non-opioid analgesic.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Pain Medication Usage	871 milligrams Interval 318.0 to 1425.0

PRIMARY outcome

Timeframe: Day 3

Average milligram per day of a non-opioid analgesic.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=10 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Pain Medication Usage	780 milligrams Interval 394.0 to 1167.0

SECONDARY outcome

Timeframe: Day 3

Number responding to the following question will be recorded: 1\. "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." Range 0-5 with higher score indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=10 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. Very satisfied	0 Participants
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. Very dissatisfied	0 Participants
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. Dissatisfied	0 Participants
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. Somewhat dissatisfied	0 Participants
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. Somewhat satisfied	6 Participants
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. Satisfied	4 Participants

SECONDARY outcome

Timeframe: Day 3

Number responding to the following question will be recorded: 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).

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=10 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention. Yes, I would consider using in the future	8 Participants
Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention. Maybe	2 Participants
Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention. No, would not use again	0 Participants

SECONDARY outcome

Timeframe: Day 1

The Interventionist (Acupressure nurse) will be asked to capture time related to completion of study tasks and other qualitative questions to assess overall feasibility. Time recorded in minutes.

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
BAA Press Placement Survey (Interventionists Only) - Mean Time of Acupressure Seed Placement	11.5 minutes Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline

GAD-7 is 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 score ranges from 0-21. Higher scores indicate increased severity of anxiety. 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 score ranges from 0-21. Higher scores indicate increased severity of anxiety

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
General Anxiety Disorder Scale (GAD-7)	15.0 score on a scale Interval 10.8 to 19.2

SECONDARY outcome

Timeframe: Day 1

GAD-7 is 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 score ranges from 0-21. Higher scores indicate increased severity of anxiety. 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 score ranges from 0-21. Higher scores indicate increased severity of anxiety

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
General Anxiety Disorder Scale (GAD-7)	9.7 score on a scale Interval 4.4 to 15.1

SECONDARY outcome

Timeframe: Day 2

GAD-7 is 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 score ranges from 0-21. Higher scores indicate increased severity of anxiety. 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 score ranges from 0-21. Higher scores indicate increased severity of anxiety

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=11 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
General Anxiety Disorder Scale (GAD-7)	7.1 score on a scale Interval 3.4 to 10.9

SECONDARY outcome

Timeframe: Day 3

GAD-7 is 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 score ranges from 0-21. Higher scores indicate increased severity of anxiety. 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 score ranges from 0-21. Higher scores indicate increased severity of anxiety

Outcome measures

Outcome measures
Measure	Auricular Acupressure Pad Group n=10 Participants All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
General Anxiety Disorder Scale (GAD-7)	5.7 score on a scale Interval 2.5 to 9.0

Adverse Events

Auricular Acupressure Pad 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

Adverse event data not reported

Additional Information

Michelle Olshan-Perlmutter

Wake Forest University Health Sciences

Phone: 704-358-2800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place