Nurse Initiated Acupressure for Pain Management

Not Applicable

Completed

• Conditions: Pain, Acute; Pain, Postoperative
• Interventions: Device: Auricular acupressure; Other: Standard of care pain management

• Registration Number: NCT04044716
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2019-12-31
• Primary Completion: 2021-10-04
• Study Completion: 2021-10-04
• Results First Submitted: 2022-09-19
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Results First Posted: 2022-12-07
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Adults 18-80 admitted for knee or hip arthroplasty
• Pre-surgery morphine equivalent < 50
• American Society of Anaesthesiologists (ASA) score < 3

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Exclusion Criteria

• Participants with a history of skin disease (psoriasis), adhesive allergy, history of delirium, or cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular acupressure Group	Standard of care pain management	The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively.
Auricular acupressure Group	Auricular acupressure	The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively.
Standard of care Group	Standard of care pain management	Participants in this group will receive standard of care pain management by the treating physician.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Pain Scale	Up to Post-operatively day 4, at the end of the day approximately 10 pm	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.
Medication Use - Inpatient Opioids	Up to post-operatively day 4	Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)
Medication Use - Outpatient Opioids	Up to post-operatively day 4	Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively
Medication Use - Total Other Analgesics	Up to post-operatively day 4	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.

Secondary Outcome Measures

Name	Time	Method
Mean Number of Pellets Retained	Up to post-operatively day 4	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.
Number of Participants Who Responded "Yes, Would Definitely Consider Using in the Future."	post-operatively day 4	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."
Visual Analogue Pain Scale	post-operatively day 4, at the end of the day	Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Number of Participants Who Responded They Were Satisfied With Pain Management	post-operatively day 4	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
Nurse Time to Deploy Pellets	post-operatively day 5	Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction.
Number of Nurse Concerns Reported	post-operatively day 0 and 1	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.

Trial Locations

Locations (1)

Davie Medical Center; 🇺🇸 Bermuda Run, North Carolina, United States