insomnia. Insomnia
Conditions
Interventions
Intervention 1: Experimental group: 0.1 mg/kg of melatonin (Nature Made, USA) on a daily basis for one month. Intervention 2: Control group: 0.1 mg/kg of placebo (... , Iran) on a daily basis for one
Sponsors
Qazvin University of Medical Sciences
Qazvin University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 3 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Weight. Timepoint: Immediately before the treatment and one month after going on melatonin. Method of measurement: Digital weighing scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKhatereh Khamenehpour
Qazvin University of Medical Sciences
Outcome results
None listed