Nurse Initiated Acupressure for Pain Management

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04044716
Collaborator
(none)
60
1
2
21.1
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Auricular acupressure
  • Other: Standard of care pain management
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nurse Initiated Auricular Acupressure for Post-operative Pain Management in Knee and Hip Arthroplasty Patients
Actual Study Start Date :
Dec 31, 2019
Actual Primary Completion Date :
Oct 4, 2021
Actual Study Completion Date :
Oct 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Auricular acupressure Group

The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant 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

    Other: Standard of care pain management
    The participant post-operative pain will be managed following the standard protocol by the treating physician.

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analogue Pain Scale [Up to Post-operatively day 4, at rising]

      Total score 0 to 10, higher scores denotes worse outcomes.

    2. Visual Analogue Pain Scale [Up to Post-operatively day 4, at the end of the day]

      Total score 0 to 10, higher scores denotes worse outcomes.

    3. Medication Use - Outpatient Opioids [Up to post-operatively day 4]

      Amount of medication use will be recorded in morphine equivalent dose

    4. Medication Use - Inpatient Opioids [Up to post-operatively day 4]

      Amount of medication use will be recorded in morphine equivalent dose

    5. Medication Use - Inpatient other analgesics [Up to post-operatively day 4]

      Amount of medication use will be recorded

    Secondary Outcome Measures

    1. Visual Analogue Pain Scale [Baseline]

      Total score 0-10, higher scores denotes worse outcomes.

    2. Visual Analogue Pain Scale [Day of Surgery/Day 0, at rising]

      Total score 0-10, higher scores denotes worse outcomes.

    3. Visual Analogue Pain Scale [post-operatively day 1, at rising]

      Total score 0 to 10 , higher scores denotes worse outcomes.

    4. Visual Analogue Pain Scale [post-operatively day 2, at rising]

      Total score 0 to 10 , higher scores denotes worse outcomes.

    5. Visual Analogue Pain Scale [post-operatively day 3, at rising]

      Total score 0 to 10 , higher scores denotes worse outcomes.

    6. Visual Analogue Pain Scale [post-operatively day 4, at rising]

      Total score 0 to 10 , higher scores denotes worse outcomes.

    7. Visual Analogue Pain Scale [post-operatively day 1, at the end of the day]

      Total score 0 to 10, higher scores denotes worse outcomes.

    8. Visual Analogue Pain Scale [post-operatively day 2, at the end of the day]

      Total score 0 to 10, higher scores denotes worse outcomes.

    9. Visual Analogue Pain Scale [post-operatively day 3, at the end of the day]

      Total score 0 to 10, higher scores denotes worse outcomes.

    10. Visual Analogue Pain Scale [post-operatively day 4, at the end of the day]

      Total score 0 to 10, higher scores denotes worse outcomes.

    11. Number of days the pellets where retained [Up to post-operatively day 4]

    12. Pain Management satisfaction Questionnaire [post-operatively day 4]

      Likert scale with a total score of 0 to 6--higher scores denotes worse outcomes.

    13. Overall participant satisfaction [post-operatively day 4]

      Participants are 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."

    14. Nurse Time to deploy pellets [post-operatively day 5]

      Reported as the amount of minutes that took the nurses

    15. Nurse satisfaction questionnaire [post-operatively day 5]

      Study nurses applying the acupressure pads will be asked to give feedback related to how easily acupressure fit into their workflow and will be prompted to give additional feedback on process. Study nurses will also be asked to record in minutes the time it took to place acupressure pellet pads and provide participant instructions-measured from the time they entered the room to exit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Davie Medical Center Bermuda Run North Carolina United States 27006

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04044716
    Other Study ID Numbers:
    • IRB00057513
    First Posted:
    Aug 5, 2019
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    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
    Keywords provided by Wake Forest University Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021