Trials / Completed
CompletedNCT03968939
Total Joint Arthroplasty and Sleep
Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- James A. Keeney · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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." |
Timeline
- Start date
- 2019-10-01
- Primary completion
- 2022-03-01
- Completion
- 2022-05-22
- First posted
- 2019-05-30
- Last updated
- 2024-07-16
- Results posted
- 2024-07-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03968939. Inclusion in this directory is not an endorsement.