Battlefield Auricular Acupressure (BAApress) Feasibility Study

NCT05939388 | Completed Results FDA Device

• 1 other identifier: IRB00098172
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out what effects (good and bad) acupressure applied to the outside of the ear (Auricular Acupressure), in addition to the standard of care medication regimen, will have on pain. This study is being done to assess whether acupressure in addition to prescribed pain medication may be of benefit in decreasing pain levels and improving overall wellbeing. This study will also evaluate the feasibility of routinely offering acupressure to patients having pain issues in addition to a psychiatric diagnosis.

Conditions

Pain

Keywords

auricular acupressure; pain management; acupressure seeds; acute pain; chronic pain

Outcome Measures

Primary Outcomes (7)

• Patient Reported Pain and General Activity Scores (Visual Analogue Scale)

  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.

  Baseline

• Patient Reported Pain and General Activity Scores (Visual Analogue Scale)

  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.

  Day 1

• Patient Reported Pain and General Activity Scores (Visual Analogue Scale)

  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.

  Day 2

• Patient Reported Pain and General Activity Scores (Visual Analogue Scale)

  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.

  Day 3

• Pain Medication Usage

  Average milligram per day of a non-opioid analgesic.

  Day 1

• Pain Medication Usage

  Average milligram per day of a non-opioid analgesic.

  Day 2

• Pain Medication Usage

  Average milligram per day of a non-opioid analgesic.

  Day 3

Secondary Outcomes (7)

• Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied.

  Day 3

• Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention.

  Day 3

• BAA Press Placement Survey (Interventionists Only) - Mean Time of Acupressure Seed Placement

  Day 1

• General Anxiety Disorder Scale (GAD-7)

  Baseline

• General Anxiety Disorder Scale (GAD-7)

  Day 1

Study Arms (1)

Auricular Acupressure Pad Group

EXPERIMENTAL

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.

Device: Auricular Acupressure Pads

Interventions

Auricular Acupressure Pads DEVICE

Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.

Auricular Acupressure Pad Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring admission to psychiatric emergency room who also have documented chronic or acute pain
• History of chronic or acute pain with or without opioid use disorder
• Expected length of stay at least 2-3 days at the time of recruitment
• Able to read and understand the informed consent form

You may not qualify if:

• Since this is a feasibility pilot, only English-speaking participants will be eligible.
• Cognitive impairment (Intellectual Disability Disorder or Dementia)
• Patients who have a legal guardian
• Participants with a history of skin disease (e.g., psoriasis) involving the ear, adhesive allergy, recent scar tissue on ear, or current abrasions or cuts on ear,
• Use of some types of hearing aids (obstructing the placement of beads)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28105, United States

Location

MeSH Terms

Conditions

Pain; Agnosia; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Michelle Olshan-Perlmutter
• Organization: Wake Forest University Health Sciences

michell.olshanperlmutter@atriumhealth.org

704-358-2800

Study Officials

• Michelle Olshan-Perlmutter, PMHCNS-BC

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: November 14, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 2, 2025
• Results First Posted: December 30, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)