Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty
1 other identifier
interventional
150
1 country
1
Brief Summary
Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2026
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 29, 2026
CompletedStudy Start
First participant enrolled
August 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 4, 2026
July 29, 2026
July 1, 2026
3 months
July 22, 2026
July 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep Quality
Patient-Reported Outcomes Measurement Information System (PROMIS) for sleep quality
14 days
Study Arms (3)
5mg group
EXPERIMENTALMelatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.
10mg group
EXPERIMENTALTwo melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.
Control group
PLACEBO COMPARATORTwo placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.
Interventions
Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.
Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.
Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.
Eligibility Criteria
You may qualify if:
- Elective unilateral total hip arthroplasty.
You may not qualify if:
- Revision arthroplasty
- documented sleep disorders requiring treatment,
- use of other sleep medications preoperatively
- known melatonin allergy or contraindication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Benha Univeristy
Banhā, Qalyobua, 3433, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 22, 2026
First Posted
July 29, 2026
Study Start
August 4, 2026
Primary Completion (Estimated)
November 4, 2026
Study Completion (Estimated)
November 4, 2026
Last Updated
July 29, 2026
Record last verified: 2026-07