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Clinical Trials/NCT05939388
NCT05939388
Completed
Not Applicable

Battlefield Auricular Acupressure (BAApress) for Emergency Department Observation Psychiatric Patients With Co-occurring Chronic and Acute Pain Management

Wake Forest University Health Sciences1 site in 1 country11 target enrollmentNovember 14, 2023
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Wake Forest University Health Sciences
Enrollment
11
Locations
1
Primary Endpoint
Patient Reported Pain and General Activity Scores (Visual Analogue Scale)
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 14, 2023
End Date
March 1, 2024
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: Day 3

Average milligram per day of a non-opioid analgesic.

Secondary Outcomes

  • 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)(Day 3)

Study Sites (1)

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