Clinical trial NCT05939388: Battlefield Auricular Acupressure (BAApress) Feasibility Study
Official title: Battlefield Auricular Acupressure (BAApress) for Emergency Department Observation Psychiatric Patients With Co-occurring Chronic and Acute Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: auricular acupressure
pain management
acupressure seeds
acute pain
chronic pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Patient Reported Pain and General Activity Scores (Visual Analogue Scale)
timeFrame: Baseline
measure: Patient Reported Pain and General Activity Scores (Visual Analogue Scale)
timeFrame: Day 1
measure: Patient Reported Pain and General Activity Scores (Visual Analogue Scale)
timeFrame: Day 2
measure: Patient Reported Pain and General Activity Scores (Visual Analogue Scale)
timeFrame: Day 3
measure: Pain Medication Usage
timeFrame: Day 1
measure: Pain Medication Usage
timeFrame: Day 2
measure: Pain Medication Usage
timeFrame: Day 3
Secondary outcomes:
measure: Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied.
timeFrame: Day 3
measure: Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention.
timeFrame: Day 3
measure: BAA Press Placement Survey (Interventionists Only) - Mean Time of Acupressure Seed Placement
timeFrame: Day 1
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Day 1
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Day 2
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Day 3
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michelle Olshan-Perlmutter, PMHCNS-BC
role: PRINCIPAL_INVESTIGATOR
References: