Nurse Initiated Acupressure for Pain Management

NCT04044716 | Completed Results FDA Device

• 1 other identifier: IRB00057513
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Pain, Acute

Keywords

auricular acupressure; anesthesia

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Medication Use - Inpatient Opioids

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

  Up to post-operatively day 4

• 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 Outcomes (14)

• Visual Analogue Pain Scale

  Baseline

• Visual Analogue Pain Scale

  post-operatively day 1, at rising

• Visual Analogue Pain Scale

  post-operatively day 2, at rising

• Visual Analogue Pain Scale

  post-operatively day 3, at rising

• Visual Analogue Pain Scale

  post-operatively day 4, at rising

Study Arms (3)

Auricular acupressure Group

EXPERIMENTAL

The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively.

Device: Auricular acupressure; Other: Standard of care pain management

Standard of care Group

ACTIVE COMPARATOR

Participants in this group will receive standard of care pain management by the treating physician.

Other: Standard of care pain management

Nurse Interventionists

NO INTERVENTION

Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.

Interventions

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.

Also known as: acupressure

Auricular acupressure Group

Standard of care pain management OTHER

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

Auricular acupressure Group; Standard of care Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-80 admitted for knee or hip arthroplasty
• Pre-surgery morphine equivalent \< 50
• American Society of Anaesthesiologists (ASA) score \< 3

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Davie Medical Center

Bermuda Run, North Carolina, 27006, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Dr. Carolyn Huffman
• Organization: Atrium Health Wake Forest Baptist

cshuffma@wakehealth.edu

336.713.4018

Study Officials

• Carolyn S Huffman, WHNP, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician blinded to study arms during analysis phase.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: December 31, 2019
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: December 7, 2022
• Results First Posted: December 7, 2022

Record last verified: 2022-12

Locations

US (1)