Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin 5 MG, Melatonin 10 MG, Placebo.
- Who it may be relevant to
- Registry conditions: Sleep Disturbance. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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.
Interventions
- Drug Melatonin 5 MG
Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively. - Drug Melatonin 10 MG
Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively. - Other Placebo
Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.
Primary outcome measures
- Sleep Quality [Time frame: 14 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Benha Univeristy — Banhā
Identifiers
NCT: NCT07732725 · RC.1.5.2026