Battlefield Auricular Acupressure (BAApress) Feasibility Study

Not Applicable

Completed

Conditions: Pain

Registration Number: NCT05939388

Lead Sponsor: Wake Forest University Health Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient Reported Pain and General Activity Scores (Visual Analogue Scale)	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.
Pain Medication Usage	Day 3	Average milligram per day of a non-opioid analgesic.

Secondary Outcome Measures

Name	Time	Method
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied.	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.
Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention.	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).
BAA Press Placement Survey (Interventionists Only) - Mean Time of Acupressure Seed Placement	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.
General Anxiety Disorder Scale (GAD-7)	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