Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty

NCT07732725 — Early Phase 1, Not yet recruiting, 150 participants, Benha University

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Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty A Randomized Placebo-Controlled Double-Blind Trial

Registry	NCT07732725
Status	Not yet recruiting
Phase	Early Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	150 (Estimated)
Sponsor	Benha University (Other)
Conditions	Sleep Disturbance
Interventions	Melatonin 5 MG, Melatonin 10 MG, Placebo (Drug, other)
Dates	start 2026-08-04 (estimated), primary completion 2026-11-04 (estimated), completion 2026-11-04 (estimated), first posted 2026-07-29, last updated 2026-07-29
Locations	1 site in Egypt

-Summary

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+Detailed description

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. Also, The present study aimed to assess the value of oral melatonin 5mg and 10mg given perioperatively on sleep quality in patients submitted to total hip arthroplasty.

+Arms and interventions

Arm	Type	Interventions	Description
5mg group	Experimental	Drug: Melatonin 5 MG	Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.
10mg group	Experimental	Drug: Melatonin 10 MG	Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.
Control group	Placebo comparator	Other: Placebo	Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.

Melatonin 5 MG (Drug), also known as Melatonin: Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.
Melatonin 10 MG (Drug), also known as Melatonin: Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.
Placebo (Other): Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.

+Outcome measures

Primary outcomes

Sleep Quality [14 days]: Patient-Reported Outcomes Measurement Information System (PROMIS) for sleep quality

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Elective unilateral total hip arthroplasty.

Exclusion Criteria:

* Revision arthroplasty
* documented sleep disorders requiring treatment,
* use of other sleep medications preoperatively
* known melatonin allergy or contraindication.

+Locations (1)

Facility	City	Country	Status
Benha Univeristy	Banhā, Qalyobua	Egypt