The effect of melatonin in children insomnia
Phase 3
Recruiting
- Conditions
- insomnia.Insomnia
- Registration Number
- IRCT20180719040526N1
- Lead Sponsor
- Qazvin University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
children aged between one and three years old
Chronic insomnia
Not having taken antibiotics and antihistamines and hypnotic drugs over a period of one month before the treatment
Exclusion Criteria
Children suffering from neurological and developmental disorders
Children with chronic disease (e.g., heart, kidney, gastrointestinal)
Children suffering from anemia and blood disease
Reflux
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep duration. Timepoint: Immediately before the treatment and one month after going on melatonin. Method of measurement: Pediatric sleep clinic questionnaire: Background information.;Sleep quality. Timepoint: Immediately before the treatment and one month after going on melatonin. Method of measurement: Pediatric sleep clinic questionnaire: Background information.;Frequent waking. Timepoint: Immediately before the treatment and one month after going on melatonin. Method of measurement: Pediatric sleep clinic questionnaire: Background information.;Sleep initiation. Timepoint: Immediately before the treatment and one month after going on melatonin. Method of measurement: Pediatric sleep clinic questionnaire: Background information.
- Secondary Outcome Measures
Name Time Method Weight. Timepoint: Immediately before the treatment and one month after going on melatonin. Method of measurement: Digital weighing scale.