Battlefield Auricular Acupressure (BAApress) Feasibility Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05939388
• Other study ID #: IRB00098172
• Status: Completed
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Device:
• Auricular Acupressure Pads
Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Battlefield auricular acupressure (BAA) press question 3	Three questions will be ask of evaluate acceptance of the intervention. Responses to the following will be analyzed qualitatively: 2. 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). Will analyze with descriptive stats with percent responding to each answer. 3. Is there anything else you would like to tell us that may be helpful for us to know regarding ear acupressure? (Each answer will be collected and assessed for future studies). Will collect qualitative data for later analysis for content.	Day 3
Primary	Patient reported pain and general activity scores (Visual Analogue Scale)	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.	Baseline
Primary	Patient reported pain and general activity scores (Visual Analogue Scale)	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.	Day 1
Primary	Patient reported pain and general activity scores (Visual Analogue Scale)	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.	Day 2
Primary	Patient reported pain and general activity scores (Visual Analogue Scale)	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.	Day 3
Secondary	Pain Medication Usage	Average milligram per day sorted by medication name.	Baseline, Day 1, Day 2, Day 3
Secondary	General Anxiety Disorder Scale (GAD-7)	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	Baseline, Day 1, Day 2, Day 3
Secondary	Battlefield auricular acupressure (BAA) press Question 1	Three questions will be ask of evaluate acceptance of the intervention. Percent 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, will treat as ordinal data and provide descriptive statistics	Day 3
Secondary	Battlefield auricular acupressure (BAA) press question 2	Three questions will be ask of evaluate acceptance of the intervention. Responses to the following will be analyzed quantitative an 2. 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). Will analyze with descriptive stats with percent responding to each answer. 3. Is there anything else you would like to tell us that may be helpful for us to know regarding ear acupressure? (Each answer will be collected and assessed for future studies). Will collect qualitative data for later analysis for content.	Day 3
Secondary	BAA Press placement survey (interventionists only)	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.	Day 1
Secondary	Pain Management Satisfaction Score	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). Higher score indicates more satisfaction.	Day 3