Nurse Initiated Acupressure for Pain Management

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Pain, Acute
• Intervention / Treatment: Device: Auricular acupressure; Other: Standard of care 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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Bermuda Run, North Carolina, United States, 27006
      • Davie Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular acupressure Group; The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively.	Device: Auricular acupressure; 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.; Other Names: acupressure; Other: Standard of care pain management; The participant post-operative pain will be managed following the standard protocol by the treating physician.
Active Comparator: Standard of care Group; Participants in this group will receive standard of care pain management by the treating physician.	Other: Standard of care pain management; The participant post-operative pain will be managed following the standard protocol by the treating physician.
No Intervention: Nurse Interventionists; Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Carolyn S Huffman, WHNP, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): October 4, 2021
• Study Completion (Actual): October 4, 2021

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: anesthesia; auricular acupressure
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: IRB00057513

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No