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Efficacy of melatonin on sleep quality After spine surgery

Efficacy of melatonin on sleep quality After spine surgery Using the Pittsburgh Sleep Quality Index (PSQI)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250526065913N1
Enrollment
80
Registered
2025-08-23
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep quality.

Interventions

Intervention 1: “Patients in the intervention group will receive 42 oral tablets, taking one 6 mg melatonin tablet (brand name: SleepMed) orally each night at bedtime for 6 weeks. The melatonin tablet

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 80 Years

Inclusion criteria

Inclusion criteria: Patients Who Have Undergone Spinal Surgery and Are Able to Complete the Study

Exclusion criteria

Exclusion criteria: Patients Who Are Taking Melatonin or Other Sleep Medications, Antidepressants, Antipsychotic Drugs, Opioid Medications, and Warfarin History of Insomnia History of Obstructive Sleep Apnea Inflammatory Conditions Age Over 80

Design outcomes

Primary

MeasureTime frame
Sleep quality according to the PSQI questionnaire. Timepoint: At three time points: pre-surgery, 2 weeks post-surgery, and 6 weeks post-surgery. Method of measurement: PSQI questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParham Talebian

Tehran University of Medical Sciences

ptalebian@sina.tums.ac.ir+98 21 6312 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026