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Completed

NCT Number: NCT04044716

Nurse Initiated Acupressure for Pain Management

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.

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Key information

Conditions

Pain, Postoperative Acute Pain Neurologic Manifestations Pain Pain, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Davie Medical Center

Bermuda Run, North Carolina, 27006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular acupressure

Device

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

Standard of care pain management

Other

The participant post-operative pain will be managed following the standard protocol by the treating physician.

Primary outcomes

  1. Visual Analogue Pain Scale

    Time frame: Up to Post-operatively day 4, at rising approximately 6 am

    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.

  2. Visual Analogue Pain Scale

    Time frame: 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.

  3. Medication Use - Outpatient Opioids

    Time frame: Up to post-operatively day 4

    Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively

  4. Medication Use - Inpatient Opioids

    Time frame: Up to post-operatively day 4

    Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)

  5. Medication Use - Total Other Analgesics

    Time frame: 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 outcomes

  1. Visual Analogue Pain Scale

    Time frame: Baseline

    Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

  2. Visual Analogue Pain Scale

    Time frame: post-operatively day 1, at rising

    Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

  3. Visual Analogue Pain Scale

    Time frame: post-operatively day 2, at rising

    Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain.

  4. Visual Analogue Pain Scale

    Time frame: post-operatively day 3, at rising

    Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

  5. Visual Analogue Pain Scale

    Time frame: post-operatively day 4, at rising

    Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).

  6. Visual Analogue Pain Scale

    Time frame: post-operatively day 1, 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).

  7. Visual Analogue Pain Scale

    Time frame: post-operatively day 2, 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).

  8. Visual Analogue Pain Scale

    Time frame: post-operatively day 3, 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).

  9. Visual Analogue Pain Scale

    Time frame: 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).

  10. Mean Number of Pellets Retained

    Time frame: 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.

  11. Number of Participants Who Responded They Were Satisfied With Pain Management

    Time frame: 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

  12. Number of Participants Who Responded "Yes, Would Definitely Consider Using in the Future."

    Time frame: 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."

  13. Nurse Time to Deploy Pellets

    Time frame: post-operatively day 5

    Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction.

  14. Number of Nurse Concerns Reported

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2019
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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