Nurse Initiated Acupressure for Pain Management

Study Overview
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Brief Summary
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The purpose of pilot study is to test the feasibility of nurse initiated post-operative bilateral auricular acupressure as an adjunct to medication for post-operative pain management.

Detailed Description
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Postoperative pain management has become an area of concern over the last decade due to the opioid epidemic and concerns related to their use as the primary pain management strategy. Joint Commission requires that hospitals have additional pain non-pharmacologic pain management tools at their disposal to an effort decrease the reliance on opioids. Acupuncture and acupressure have been used for centuries in the management of a variety of disorders including pain. Unlike acupuncture, acupressure can be easily applied with limited training and is within the scope of practice for nurses, according to the North Carolina Board of Nursing. Thus evidence based non-pharmacologic strategies that can be deployed by nursing are of benefit to hospital organizations.

Official Title
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Nurse Initiated Auricular Acupressure for Post-operative Pain Management in Knee and Hip Arthroplasty Patients

Conditions
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Pain, Postoperative, Pain, Acute

Intervention / Treatment
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* Device: Auricular acupressure
* Other: Standard of care pain management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-80 admitted for knee or hip arthroplasty Pre-surgery morphine equivalent < 50 American Society of Anaesthesiologists (ASA) score < 3 Exclusion Criteria: Participants with a history of skin disease (psoriasis), adhesive allergy, history of delirium, or cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular acupressure Group<br>The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively. | Device: Auricular acupressure<br>* Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist.<br>* Other names: acupressure;Other: Standard of care pain management<br>* The participant post-operative pain will be managed following the standard protocol by the treating physician.<br>|
| Active Comparator: Standard of care Group<br>Participants in this group will receive standard of care pain management by the treating physician. | Other: Standard of care pain management<br>* The participant post-operative pain will be managed following the standard protocol by the treating physician.<br>|
| No Intervention: Nurse Interventionists<br>Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). Pain score averaged across post-op days 1 - 4. | Up to Post-operatively day 4, at rising approximately 6 am | 
| Visual Analogue Pain Scale | Average pain before bed score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).Pain score averaged across post-op days 0 - 4. | Up to Post-operatively day 4, at the end of the day approximately 10 pm | 
| Medication Use - Outpatient Opioids | Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively | Up to post-operatively day 4 | 
| Medication Use - Inpatient Opioids | Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia) | Up to post-operatively day 4 | 
| Medication Use - Total Other Analgesics | Amount of of other analgesics other than aspirin and not part of anesthesia record from immediate post-operative period to day 4 post-op in reported milligrams. | Up to post-operatively day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | Baseline | 
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 1, at rising | 
| Visual Analogue Pain Scale | Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain. | post-operatively day 2, at rising | 
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 3, at rising | 
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 4, at rising | 
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 1, at the end of the day | 
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 2, at the end of the day | 
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 3, at the end of the day | 
| Visual Analogue Pain Scale | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 4, at the end of the day | 
| Mean Number of Pellets Retained | Mean number of pellets retained on post-operative day 4. This Outcome Measure was pre-specified to be assessed for the Auricular Acupressure Group Arm only. | Up to post-operatively day 4 | 
| Number of Participants Who Responded They Were Satisfied With Pain Management | Likert scale with a total score of 0 to 6--higher scores denotes worse outcomes. Force choice: very satisfied, satisfied, somewhat satisfied, somewhat dissatisfied, dissatisfied, very dissatisfied. Any degree of satisfaction compared to any degree of dissatisfaction. Satisfied included responses very satisfied to somewhat satisfied | post-operatively day 4 | 
| Number of Participants Who Responded Yes, Would Definitely Consider Using in the Future. | Participants were asked if they would consider using auricular acupressure in the future for pain if recommended by a nurse or physician? Possible answers are no, would not use again, maybe, or Yes, would definitely consider using in the future. | post-operatively day 4 | 
| Nurse Time to Deploy Pellets | Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction. | post-operatively day 5 | 
| Number of Nurse Concerns Reported | Review nurse reports in encounters. Count number of concerns pooled across all participants in encounters with disruption of workflow due to care unit or patient barriers documented while participant was in hospital. Concerns included workflow and patient barriers. This outcome applies to nurse interventionists arm only. | post-operatively day 0 and 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auricular acupressure, anesthesia