Sleep Disturbance
Conditions
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.
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
DRUGMelatonin 5 MG
Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.
DRUGMelatonin 10 MG
Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.
OTHERPlacebo
Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 14 days | Patient-Reported Outcomes Measurement Information System (PROMIS) for sleep quality |
Countries
Egypt
Contacts
CONTACTNourhan Amer, PhD
Outcome results
None listed