Total Joint Arthroplasty and Sleep

Sponsor

James A. Keeney (Other)

Overall Status

Recruiting

CT.gov ID

NCT03968939

Collaborator

(none)

375

Enrollment

Location

Arms

43.9

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Total Hip Arthroplasty Primary Total Knee Arthroplasty	Drug: Diphenhydramine (Benadryl) Dietary Supplement: Melatonin Behavioral: Sleep Hygiene Education	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Benadryl + Melatonin Group + Sleep Hygiene Education Sleep Hygiene Education Group Control group (Usual Care)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group (Usual Care) Usual care
Active Comparator: Sleep Hygiene Education 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	Drug: Diphenhydramine (Benadryl) Oral Diphenhydramine (Benadryl), 25 mg Dietary Supplement: Melatonin Oral Melatonin, 3 mg Behavioral: Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."

Arm

Intervention/Treatment

No Intervention: Control group (Usual Care)

Usual care

Active Comparator: Sleep Hygiene Education

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

Drug: Diphenhydramine (Benadryl)

Oral Diphenhydramine (Benadryl), 25 mg

Dietary Supplement: Melatonin

Oral Melatonin, 3 mg

Behavioral: Sleep Hygiene Education

Brochure containing information about getting a "good night's sleep."

Outcome Measures

Primary Outcome Measures

Epworth Sleepiness Scale (ESS) [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
Pittsburgh Sleep Quality Index (PSQI) [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
Visual Analogue Scale (VAS) for pain [12 weeks post-op]
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients undergoing elective primary total hip or knee arthroplasty

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri Health System	Columbia	Missouri	United States	65212

Sponsors and Collaborators

James A. Keeney

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James A. Keeney, Chief Adult Hip and Knee Reconstruction Service, Department of Orthopaedic Surgery, University of Missouri, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT03968939

Other Study ID Numbers:

2013726

First Posted:

May 30, 2019

Last Update Posted:

Oct 27, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Diphenhydramine

Promethazine

Melatonin

Study Results

No Results Posted as of Oct 27, 2021