The current protocol was aimed to compare the effect of melatonin and placebo on the quality of sleep in patients admitted in Post Coronary Care Unit. In overall, 110 patients were participated in the study. Patients were randomly allocated into two groups of intervention and control using block allocation method (block size 4). The intervention group received a 3 mg melatonin tablet 30 minutes before bedtime at night for two weeks. The control group also received a 3 mg placebo tablet included chickpea flour30 minutes before bedtime at night. The placebo tablet was made in the same form and size with the melatonin tablet. It was double blind study that person who evaluates sleep quality and also patients were not aware of participation assigned to groups. An inclusion criterion was as follow: patients admitted in post coronary care unit that their sleep questionnaires score were more than fifteen. Exclusion criteria were considered as: chronic pain; psychology disorder; using sedative medications. Quality of sleep was evaluated by using of Petersburg sleep quality questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081010340N18
Registration date:2017-09-04, 1396/06/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of melatonin and placebo on the quality of sleep in patients admitted in Post Coronary Care Unit
Public title
The effect of melatonin on the quality of sleep
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients admitted in post coronary care unit that their sleep questionnaires score were more than fifteen.
Exclusion criteria : chronic pain; psychology disorder; using sedative medications.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Golestan University of Medical Sciences
Street address
Falsafi educational campus, Vice Chancellor of Technology and Information, 4 Kilometer of Gorgan-sari Road, Gorgan
City
Gorgan
Postal code
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.GOUMS.REC.1396.83
Health conditions studied
1
Description of health condition studied
Sleep Disorder
ICD-10 code
F51
ICD-10 code description
Nonorganic sleep disorders
Primary outcomes
1
Description
Sleep quality
Timepoint
Before intervention and 14 day after intervention
Method of measurement
Petersburg sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received a 3 mg melatonin tablet 30 minutes before bedtime at night for two weeks.
Category
Treatment - Drugs
2
Description
The control group also received a 3 mg placebo tablet included chickpea flour 30 minutes before bedtime at night for two weeks.