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Nurse Initiated Acupressure for Pain Management

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ClinicalTrials.gov Identifier: NCT04044716
Recruitment Status : Suspended (COVID 19)
First Posted : August 5, 2019
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Pain, Acute Device: Auricular acupressure Other: Standard of care pain management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 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 : December 31, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Visual Analogue Pain Scale [ Time Frame: Up to Post-operatively day 4, at rising ]
    Total score 0 to 10, higher scores denotes worse outcomes.

  2. Visual Analogue Pain Scale [ Time Frame: 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 [ Time Frame: Up to post-operatively day 4 ]
    Amount of medication use will be recorded in morphine equivalent dose

  4. Medication Use - Inpatient Opioids [ Time Frame: Up to post-operatively day 4 ]
    Amount of medication use will be recorded in morphine equivalent dose

  5. Medication Use - Inpatient other analgesics [ Time Frame: Up to post-operatively day 4 ]
    Amount of medication use will be recorded


Secondary Outcome Measures :
  1. Visual Analogue Pain Scale [ Time Frame: Baseline ]
    Total score 0-10, higher scores denotes worse outcomes.

  2. Visual Analogue Pain Scale [ Time Frame: Day of Surgery/Day 0, at rising ]
    Total score 0-10, higher scores denotes worse outcomes.

  3. Visual Analogue Pain Scale [ Time Frame: post-operatively day 1, at rising ]
    Total score 0 to 10 , higher scores denotes worse outcomes.

  4. Visual Analogue Pain Scale [ Time Frame: post-operatively day 2, at rising ]
    Total score 0 to 10 , higher scores denotes worse outcomes.

  5. Visual Analogue Pain Scale [ Time Frame: post-operatively day 3, at rising ]
    Total score 0 to 10 , higher scores denotes worse outcomes.

  6. Visual Analogue Pain Scale [ Time Frame: post-operatively day 4, at rising ]
    Total score 0 to 10 , higher scores denotes worse outcomes.

  7. Visual Analogue Pain Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to post-operatively day 4 ]
  12. Pain Management satisfaction Questionnaire [ Time Frame: post-operatively day 4 ]
    Likert scale with a total score of 0 to 6--higher scores denotes worse outcomes.

  13. Overall participant satisfaction [ Time Frame: 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 [ Time Frame: post-operatively day 5 ]
    Reported as the amount of minutes that took the nurses

  15. Nurse satisfaction questionnaire [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044716


Locations
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United States, North Carolina
Davie Medical Center
Bermuda Run, North Carolina, United States, 27006
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Carolyn S Huffman, WHNP, PhD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04044716    
Other Study ID Numbers: IRB00057513
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: July 2019

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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:
auricular acupressure
anesthesia
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms