Battlefield Auricular Acupressure (BAApress) Feasibility Study

NCT ID: NCT05939388

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2024-03-01

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.

Detailed Description

The purpose of this study is to test the feasibility of Emergency Department nurse-initiated battlefield auricular acupressure as an adjunct to medication for pain management for psychiatric Emergency Department Observation patients.

The Battlefield Auricula Acupressure interventionists (nurse) will complete Auricular training modules and complete competency assessments and intervention assessments throughout the study. Study interventionist will include the possibility that a study participant may be part of a competency assessment and that their session may be recorded and securely uploaded to a server per Institutional Review Board (IRB) and institutional policies.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Auricular Acupressure Pads

Intervention Type: DEVICE

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

Interventions

Auricular Acupressure Pads

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Olshan-Perlmutter, PMHCNS-BC

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00098172

Identifier Type: -

Identifier Source: org_study_id