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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular Acupressure Pads | Device | Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Pain Medication Usage | Average milligram per day of a non-opioid analgesic. | Day 1 |
| Pain Medication Usage |
| Measure | Description | Time Frame |
|---|---|---|
| Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Number 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 with higher score indicating higher satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Olshan-Perlmutter, PMHCNS-BC | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health | Charlotte | North Carolina | 28105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Auricular Acupressure Pad Group | 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. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Auricular Acupressure Pad Group | 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. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | mm | Baseline |
|
Baseline through day 3.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auricular Acupressure Pad Group | 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. Auricular Acupressure Pads: Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Olshan-Perlmutter | Wake Forest University Health Sciences | 704-358-2800 | michell.olshanperlmutter@atriumhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2023 | Dec 3, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 29, 2023 | Jun 28, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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Average milligram per day of a non-opioid analgesic.
| Day 2 |
| Pain Medication Usage | Average milligram per day of a non-opioid analgesic. | Day 3 |
| 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). | 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. | 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 | 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 | 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 | 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 | Day 3 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | mm | 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. | Posted | Mean | 95% Confidence Interval | mm | 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. | Posted | Mean | 95% Confidence Interval | mm | Day 3 |
|
|
|
| Primary | Pain Medication Usage | Average milligram per day of a non-opioid analgesic. | Posted | Mean | 95% Confidence Interval | milligrams | Day 1 |
|
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| Primary | Pain Medication Usage | Average milligram per day of a non-opioid analgesic. | Posted | Mean | 95% Confidence Interval | milligrams | Day 2 |
|
|
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| Primary | Pain Medication Usage | Average milligram per day of a non-opioid analgesic. | Posted | Mean | 95% Confidence Interval | milligrams | Day 3 |
|
|
|
| Secondary | Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Number 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 with higher score indicating higher satisfaction. | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Day 1 |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Day 2 |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Day 3 |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Somewhat satisfied |
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| Satisfied |
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| Very satisfied |
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