Total Joint Arthroplasty and Sleep

June 20, 2024 updated by: James A. Keeney

Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training

To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

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
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Vicki L Jones

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All patients undergoing elective primary total hip or knee arthroplasty

Exclusion Criteria:

  1. History of substance abuse
  2. Workman's compensation patients
  3. Revision joint replacement
  4. History of prescription or over-the- counter sleep aid use

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group (Usual Care)
Control Group (Usual Care): Participants do not use any type of sleep education or non-prescription sleep medications to assist with getting a "good night's sleep".
Active Comparator: Sleep Hygiene Education
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
Behavioral: Sleep Hygiene Education
Brochure containing information about getting a "good night's sleep."
Active Comparator: Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)

Participants are given both:

  1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
  2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
Behavioral: Sleep Hygiene Education
Brochure containing information about getting a "good night's sleep."
Drug: Diphenhydramine (Benadryl)
Oral Diphenhydramine (Benadryl), 25 mg
Dietary supplement: Melatonin
Oral Melatonin, 3 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale (ESS)
Time Frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op

Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which to rate the participants tendency to become sleepy.

  • No chance of dozing = 0
  • Slight chance of dozing = 1
  • Moderate chance of dozing = 2
  • High chance of dozing = 3

Total the values of the responses. The total score is based on a scale of 0 to 24. The higher score the higher the chance the participant is experiencing excessive sleepiness.
Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op

The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the nine component scores, providing an overall score ranging from 0 to 27, where lower scores denote a healthier sleep quality.
Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Visual Analogue Scale (VAS) for Pain
Time Frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Baseline, 2 weeks, 6 weeks and 12 weeks post-op

Collaborators and Investigators

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

Sponsor

James A. Keeney

Investigators

  • Principal Investigator: James A Keeney, MD, University of Missouri Health System, Department of Orthopaedic Surgery

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)

October 1, 2019

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

May 22, 2022

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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