Pain
Conditions
Keywords
auricular acupressure, pain management, acupressure seeds, acute pain, chronic pain
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 Institutional Review Board (IRB) and institutional policies.
Interventions
DEVICEAuricular Acupressure Pads
Pads containing seeds that are placed on specific sites of the ear that are thought to help with pain.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain and General Activity Scores (Visual Analogue Scale) | 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. |
| Pain Medication Usage | Day 1 | Average milligram per day of a non-opioid analgesic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Day 3 | 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. |
| Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention. | 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). |
| BAA Press Placement Survey (Interventionists Only) - Mean Time of Acupressure Seed Placement | 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. |
| General Anxiety Disorder Scale (GAD-7) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Auricular Acupressure Pad Group |
|---|---|
| Age, Continuous | 49.64 years STANDARD_DEVIATION 14.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Pain Medication Usage
Average milligram per day of a non-opioid analgesic.
Time frame: Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | Pain Medication Usage | 291 milligrams |
Primary
Pain Medication Usage
Average milligram per day of a non-opioid analgesic.
Time frame: Day 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | Pain Medication Usage | 871 milligrams |
Primary
Pain Medication Usage
Average milligram per day of a non-opioid analgesic.
Time frame: Day 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | Pain Medication Usage | 780 milligrams |
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.
Time frame: Day 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | Patient Reported Pain and General Activity Scores (Visual Analogue Scale) | 42.2 mm |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | Patient Reported Pain and General Activity Scores (Visual Analogue Scale) | 65 mm |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | Patient Reported Pain and General Activity Scores (Visual Analogue Scale) | 57.3 mm |
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.
Time frame: Day 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | Patient Reported Pain and General Activity Scores (Visual Analogue Scale) | 52.7 mm |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Pad Group | BAA Press Placement Survey (Interventionists Only) - Mean Time of Acupressure Seed Placement | 11.5 minutes | Standard Deviation 3.7 |
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.
Time frame: Day 3
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Somewhat satisfied | 6 Participants |
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Very dissatisfied | 0 Participants |
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Dissatisfied | 0 Participants |
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Somewhat dissatisfied | 0 Participants |
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Satisfied | 4 Participants |
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 1 - Count of Participants Somewhat Satisfied or Satisfied. | Very satisfied | 0 Participants |
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).
Time frame: Day 3
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention. | Yes, I would consider using in the future | 8 Participants |
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention. | Maybe | 2 Participants |
| Auricular Acupressure Pad Group | Battlefield Auricular Acupressure (BAA) Press Question 2 - Count of Participants That Would Maybe Consider or Consider Intervention. | No, would not use again | 0 Participants |
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | General Anxiety Disorder Scale (GAD-7) | 15.0 score on a scale |
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
Time frame: Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | General Anxiety Disorder Scale (GAD-7) | 9.7 score on a scale |
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
Time frame: Day 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | General Anxiety Disorder Scale (GAD-7) | 7.1 score on a scale |
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
Time frame: Day 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Acupressure Pad Group | General Anxiety Disorder Scale (GAD-7) | 5.7 score on a scale |