Nurse Initiated Acupressure for Pain Management

NCT ID: NCT04044716

Last Updated: 2022-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2021-10-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Statistician blinded to study arms during analysis phase.

Study Groups

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Auricular acupressure Group

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

Group Type EXPERIMENTAL

Auricular acupressure

Intervention Type 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.

Standard of care pain management

Intervention Type OTHER

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

Standard of care Group

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

Group Type ACTIVE_COMPARATOR

Standard of care pain management

Intervention Type OTHER

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

Nurse Interventionists

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Standard of care pain management

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

Intervention Type OTHER

Other Intervention Names

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acupressure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolyn S Huffman, WHNP, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Davie Medical Center

Bermuda Run, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00057513

Identifier Type: -

Identifier Source: org_study_id

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