Nurse Initiated Acupressure for Pain Management

December 6, 2022 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Bermuda Run, North Carolina, United States, 27006
        • Davie Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Auricular acupressure Group
The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group 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 Names:
  • 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
Participants in this group will receive standard of care pain management by the treating physician.
Other: Standard of care pain management
The participant post-operative pain will be managed following the standard protocol by the treating physician.
No Intervention: Nurse Interventionists
Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to Post-operatively day 4, at rising approximately 6 am
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.
Up to Post-operatively day 4, at the end of the day approximately 10 pm
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
Up to post-operatively day 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)
Up to post-operatively day 4
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.
Up to post-operatively day 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline
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).
post-operatively day 1, at rising
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.
post-operatively day 2, at rising
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).
post-operatively day 3, at rising
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).
post-operatively day 4, at rising
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).
post-operatively day 1, at the end of the day
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).
post-operatively day 2, at the end of the day
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).
post-operatively day 3, at the end of the day
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).
post-operatively day 4, at the end of the day
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.
Up to post-operatively day 4
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
post-operatively day 4
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."
post-operatively day 4
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.
post-operatively day 5
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.
post-operatively day 0 and 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carolyn S Huffman, WHNP, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00057513

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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