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The effect of Melatonin for sleep and function of shift workers

Effects of Melatonin on Sleep Quality and Cognitive Function of Shift Workers with Sleep Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090117001556N153
Enrollment
70
Registered
2023-07-22
Start date
2023-07-22
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Sleep disorder. Sleep disorders not due to a substance or known physiological condition

Interventions

Intervention 1: Intervention group: Melatonin (C13H16N2O2) in the form of tablets with a dose of 5 mg produced by Jalinous Pharmaceutical Company, administered orally 30 minutes before the person's de

Sponsors

Department of Health, Rescue and Treatment of I.R.Iran Police Force, Applied Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 55 Years

Inclusion criteria

Inclusion criteria: Being a resident physician with night shift work Age between 25 and 55 years Working at least seven night shifts in the past month Having an schedule to work at least seven night shifts during the study month Complaining about sleep disturbance after shift work and poor sleep quality (Cut-off value greater than 4 in shortPSQI)

Exclusion criteria

Exclusion criteria: Complaining about sleep disturbance during normal sleeping hours (always and not related to the night shift) Pregnancy, breastfeeding or intention to become pregnant in female participants History of sensitivity or side effects after taking melatonin and its agonists History of thyroid, cardiovascular, kidney, and endocrine diseases and psychiatric disorders (except sleep disorder) Working less than six night shifts during the study month

Design outcomes

Primary

MeasureTime frame
Sleep Quality. Timepoint: Baseline, Week 1, and Week 4. Method of measurement: Short Pittsburgh Sleep Quality Index.

Secondary

MeasureTime frame
Occupational Cognitive Failure. Timepoint: Baseline, Week 1, and Week 4. Method of measurement: Occupational Cognitive Failure Questionnaire.;Side effects. Timepoint: Baseline, Week 1, Week 4, and whenever the participant experiences a complication, by phone. Method of measurement: Checklist of side effects in which the side effects of melatonin are clearly reported, and it is possible for the participant to report other side effects that are not included in it.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSajad Khanjani

Department of Health, Rescue and Treatment of I.R.Iran Police Force, Applied Research Center

khanjanis23@yahoo.com+98 21 8123 5481

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026