Total Joint Arthroplasty and Sleep

October 25, 2021 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

375

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 Contact

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri Health System

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

Genders Eligible for Study

All

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)
Usual care
Active Comparator: Sleep Hygiene Education
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)
Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) and Sleep Hygiene Education
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: 12 weeks post-op

Patient Reported Outcome Measure - assess the "daytime sleepiness of the patient"

Scale: 0-3. 0 being never dozing, 3 being high chance of dozing
12 weeks post-op
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 12 weeks post-op

Patient Reported Outcome Measure - measure the quality and patterns of sleep in the older adult

Scale: 0-3. 0 no trouble sleeping in the past month/very good sleep, 3 three or more times having trouble sleeping in the past month/very bad sleep
12 weeks post-op
Visual Analogue Scale (VAS) for pain
Time Frame: 12 weeks post-op
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
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 (Anticipated)

May 30, 2023

Study Completion (Anticipated)

May 30, 2023

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)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

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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