Total Joint Arthroplasty and Sleep

Primary Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968939
• Other study ID #: 2013726
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2021
• Source: University of Missouri-Columbia
• Contact: Stacee W Baker, BSN, RN
• Phone: 573-884-9017
• Email: bakersa[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Primary Total Hip Arthroplasty
• Primary Total Knee Arthroplasty

Intervention

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."

Locations

Country	Name	City	State
United States	University of Missouri Health System	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
James A. Keeney

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epworth Sleepiness Scale (ESS)	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
Primary	Pittsburgh Sleep Quality Index (PSQI)	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
Primary	Visual Analogue Scale (VAS) for pain	Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain	12 weeks post-op