At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 55 enrolled
Drug / intervention
Diphenhydramine (Benadryl) +2 moredrug
Likely dose
Diphenhydramine (Benadryl) 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training
In Brief
A Phase 4 clinical trial evaluating Diphenhydramine (Benadryl), Melatonin, and 1 other intervention for Primary Total Hip Arthroplasty and Primary Total Knee Arthroplasty. Completed, enrolled 55 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartOct 2019
Primary CompletionMar 2022
Study CompletionMay 2022
TodayJul 2026
First PostedMay 30, 2019
Enrollment StartOct 1, 2019
Primary CompletionMar 1, 2022
Study CompletionMay 22, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.1 years ago
Interventions
Diphenhydramine (Benadryl)drug
Oral Diphenhydramine (Benadryl), 25 mg
Melatonindietary
Oral Melatonin, 3 mg
Sleep Hygiene Educationbehavioral
Brochure containing information about getting a "good night's sleep."