Back to resultsBattlefield Auricular Acupressure (BAApress) Feasibility Study
Primary Purpose
Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular Acupressure Pads
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring auricular acupressure, pain management, acupressure seeds, acute pain, chronic pain
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)
Sites / Locations
- Atrium Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Auricular Acupressure Pad Group
Arm Description
All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Pain Medication Usage
Average milligram per day sorted by medication name.
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
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
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.
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.
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.
Full Information
NCT ID
NCT05939388
First Posted
July 3, 2023
Last Updated
October 24, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05939388
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 IRB and institutional policies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
auricular acupressure, pain management, acupressure seeds, acute pain, chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Auricular Acupressure Pad Group
Arm Type
Experimental
Arm Description
All subjects who qualify and agree to be in the study will be given Auricular Acupressure using an acupressure pad containing acupressure seeds for 4 days in addition to their regular standard of care pain medication.
Intervention Type
Device
Intervention Name(s)
Auricular Acupressure Pads
Intervention Description
Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Primary Outcome Measure Information:
Title
Patient reported pain and general activity scores (Visual Analogue Scale)
Description
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.
Time Frame
Baseline
Title
Patient reported pain and general activity scores (Visual Analogue Scale)
Description
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.
Time Frame
Day 1
Title
Patient reported pain and general activity scores (Visual Analogue Scale)
Description
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.
Time Frame
Day 2
Title
Patient reported pain and general activity scores (Visual Analogue Scale)
Description
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.
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Pain Medication Usage
Description
Average milligram per day sorted by medication name.
Time Frame
Baseline, Day 1, Day 2, Day 3
Title
General Anxiety Disorder Scale (GAD-7)
Description
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
Time Frame
Baseline, Day 1, Day 2, Day 3
Title
Battlefield auricular acupressure (BAA) press Question 1
Description
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
Time Frame
Day 3
Title
Battlefield auricular acupressure (BAA) press question 2
Description
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.
Time Frame
Day 3
Title
BAA Press placement survey (interventionists only)
Description
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.
Time Frame
Day 1
Title
Pain Management Satisfaction Score
Description
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.
Time Frame
Day 3
Other Pre-specified Outcome Measures:
Title
Battlefield auricular acupressure (BAA) press question 3
Description
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.
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Olshan-Perlmutter, PMHCNS-BC
Phone
704-358-2800
Email
michell.olshanperlmutter@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Olshan-Perlmutter, PMHCNS-BC
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Olshan-Perlmutter, PMHCNS-BC
Phone
704-358-2800
Email
michell.olshanperlmutter@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Michelle Olshan-Perlmutter, PMHCNS-BC
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Battlefield Auricular Acupressure (BAApress) Feasibility Study
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