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NCT Number: NCT05939388

Battlefield Auricular Acupressure (BAApress) Feasibility Study

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.

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Key information

Conditions

Pain Acute Pain Agnosia Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health

Charlotte, North Carolina, 28105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Auricular Acupressure Pads

Device

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

Primary outcomes

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

    Time frame: Baseline

    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.

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

    Time frame: Day 1

    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.

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

    Time frame: Day 2

    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.

  4. 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.

  5. Pain Medication Usage

    Time frame: Day 1

    Average milligram per day of a non-opioid analgesic.

  6. Pain Medication Usage

    Time frame: Day 2

    Average milligram per day of a non-opioid analgesic.

  7. Pain Medication Usage

    Time frame: Day 3

    Average milligram per day of a non-opioid analgesic.

Secondary outcomes

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

    Time frame: Day 3

    Number responding to the following question will be recorded:

    • "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.

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

    Time frame: 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).

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

    Time frame: 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.

  4. General Anxiety Disorder Scale (GAD-7)

    Time frame: Baseline

    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

  5. General Anxiety Disorder Scale (GAD-7)

    Time frame: Day 1

    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

  6. General Anxiety Disorder Scale (GAD-7)

    Time frame: Day 2

    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

  7. General Anxiety Disorder Scale (GAD-7)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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