PainNCT05939388
Battlefield Auricular Acupressure (BAApress) Feasibility Study
A study testing Auricular Acupressure Pads in people with Pain, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Auricular Acupressure Pads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Battlefield Auricular Acupressure (BAApress) for Emergency Department Observation Psychiatric Patients With Co-occurring Chronic and Acute Pain Management
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Auricular Acupressure Pads
- Keywords
- auricular acupressure, pain management, acupressure seeds, acute pain, chronic pain
- Medical subject headings
- Pain, Agnosia, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Acupressure PadsDevice
Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupressure Pad Group | Experimental | 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. Receives: Device: Auricular Acupressure Pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Day 1
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.
Measured: Day 2
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.
Measured: Day 3
Pain Medication Usage
Average milligram per day of a non-opioid analgesic.
Measured: Day 1
Pain Medication Usage
Average milligram per day of a non-opioid analgesic.
Measured: Day 2
Pain Medication Usage
Average milligram per day of a non-opioid analgesic.
Measured: Day 3
Secondary outcomes (7)
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied.
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.
Measured: Day 3
Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention.
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).
Measured: Day 3
BAA Press Placement Survey (Interventionists Only) - Mean Time of Acupressure Seed Placement
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.
Measured: Day 1
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
Measured: Baseline
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
Measured: Day 1
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
Measured: Day 2
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
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start14 Nov 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Olshan-Perlmutter, PMHCNS-BC, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939388
- Sponsor's protocol ID
- IRB00098172
- Status last verified
- Jun 2025
- First submitted
- 3 Jul 2023
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Battlefield Auricular Acupressure (BAApress) for Emergency Department Observation Psychiatric Patients With Co-occurring Chronic and Acute Pain Management
- ClinicalTrials.gov ID
- NCT05939388
- Acronym / sponsor ID
- IRB00098172
- Conditions
- Pain
- Keywords
- auricular acupressure, pain management, acupressure seeds, acute pain, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Posted 30 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupressure Pad Group | Experimental | Device: Auricular Acupressure PadsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Acupressure PadsPads containing seeds that are placed on specific sites of the ear that are thought to help with pain. | Device | Auricular Acupressure Pad Group |
Primary outcome
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.
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.
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.
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 1
Average milligram per day of a non-opioid analgesic.
Pain Medication Usage
Time frame: Day 2
Average milligram per day of a non-opioid analgesic.
Pain Medication Usage
Time frame: Day 3
Average milligram per day of a non-opioid analgesic.
7 secondary outcomes
Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied.
Time frame: Day 3
Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention.
Time frame: Day 3
BAA Press Placement Survey (Interventionists Only) - Mean Time of Acupressure Seed Placement
Time frame: Day 1
General Anxiety Disorder Scale (GAD-7)
Time frame: Baseline
General Anxiety Disorder Scale (GAD-7)
Time frame: Day 1
General Anxiety Disorder Scale (GAD-7)
Time frame: Day 2
General Anxiety Disorder Scale (GAD-7)
Time frame: Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Olshan-Perlmutter, PMHCNS-BC principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupressure Pads in people with Pain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Pain and General Activity Scores (Visual Analogue Scale) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.