Nurse Initiated Acupressure for Pain Management
Primary Purpose
Pain, Postoperative, Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular acupressure
Standard of care pain management
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring auricular acupressure, anesthesia
Eligibility Criteria
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
Sites / Locations
- Davie Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Auricular acupressure Group
Standard of care Group
Nurse Interventionists
Arm Description
The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively.
Participants in this group will receive standard of care pain management by the treating physician.
Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.
Outcomes
Primary Outcome Measures
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.
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.
Medication Use - Outpatient Opioids
Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively
Medication Use - Inpatient Opioids
Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)
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.
Secondary Outcome Measures
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Visual Analogue Pain Scale
Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain.
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Visual Analogue Pain Scale
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
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.
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
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."
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.
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.
Full Information
NCT ID
NCT04044716
First Posted
August 1, 2019
Last Updated
December 6, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04044716
Brief Title
Nurse Initiated Acupressure for Pain Management
Official Title
Nurse Initiated Auricular Acupressure for Post-operative Pain Management in Knee and Hip Arthroplasty Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
October 4, 2021 (Actual)
Study Completion Date
October 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Acute
Keywords
auricular acupressure, anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group
Masking
Outcomes Assessor
Masking Description
Statistician blinded to study arms during analysis phase.
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular acupressure Group
Arm Type
Experimental
Arm Description
The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively.
Arm Title
Standard of care Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive standard of care pain management by the treating physician.
Arm Title
Nurse Interventionists
Arm Type
No Intervention
Arm Description
Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.
Intervention Type
Device
Intervention Name(s)
Auricular acupressure
Other Intervention Name(s)
acupressure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care pain management
Intervention Description
The participant post-operative pain will be managed following the standard protocol by the treating physician.
Primary Outcome Measure Information:
Title
Visual Analogue Pain Scale
Description
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.
Time Frame
Up to Post-operatively day 4, at rising approximately 6 am
Title
Visual Analogue Pain Scale
Description
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.
Time Frame
Up to Post-operatively day 4, at the end of the day approximately 10 pm
Title
Medication Use - Outpatient Opioids
Description
Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively
Time Frame
Up to post-operatively day 4
Title
Medication Use - Inpatient Opioids
Description
Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)
Time Frame
Up to post-operatively day 4
Title
Medication Use - Total Other Analgesics
Description
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.
Time Frame
Up to post-operatively day 4
Secondary Outcome Measure Information:
Title
Visual Analogue Pain Scale
Description
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time Frame
Baseline
Title
Visual Analogue Pain Scale
Description
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time Frame
post-operatively day 1, at rising
Title
Visual Analogue Pain Scale
Description
Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain.
Time Frame
post-operatively day 2, at rising
Title
Visual Analogue Pain Scale
Description
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time Frame
post-operatively day 3, at rising
Title
Visual Analogue Pain Scale
Description
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time Frame
post-operatively day 4, at rising
Title
Visual Analogue Pain Scale
Description
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time Frame
post-operatively day 1, at the end of the day
Title
Visual Analogue Pain Scale
Description
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time Frame
post-operatively day 2, at the end of the day
Title
Visual Analogue Pain Scale
Description
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time Frame
post-operatively day 3, at the end of the day
Title
Visual Analogue Pain Scale
Description
Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time Frame
post-operatively day 4, at the end of the day
Title
Mean Number of Pellets Retained
Description
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.
Time Frame
Up to post-operatively day 4
Title
Number of Participants Who Responded They Were Satisfied With Pain Management
Description
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
Time Frame
post-operatively day 4
Title
Number of Participants Who Responded "Yes, Would Definitely Consider Using in the Future."
Description
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."
Time Frame
post-operatively day 4
Title
Nurse Time to Deploy Pellets
Description
Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction.
Time Frame
post-operatively day 5
Title
Number of Nurse Concerns Reported
Description
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.
Time Frame
post-operatively day 0 and 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn S Huffman, WHNP, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davie Medical Center
City
Bermuda Run
State/Province
North Carolina
ZIP/Postal Code
27006
Country
United States
12. IPD Sharing Statement
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Nurse Initiated Acupressure for Pain Management
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