Nurse Initiated Acupressure for Pain Management

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044716
• Other study ID #: IRB00057513
• Status: Completed
• Phase: N/A
• Start date: December 31, 2019
• Est. completion date: October 4, 2021

Study information

• Verified date: December 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 4, 2021
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	Davie Medical Center	Bermuda Run	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Medication Use - Inpatient Opioids	Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)	Up to post-operatively day 4
Primary	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	Visual Analogue Pain Scale	Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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