The effect of melatonin on sleep quality in patients with mild traumatic brain injury
Phase 3
- Conditions
- mild traumatic brain injury.ConcussionS06.0X
- Registration Number
- IRCT20220504054738N1
- Lead Sponsor
- Kashan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not having a proved sleep disorder
History of mTBI during one past month
Not having allergy to both if the drugs
Not having hepatic failure
Not having respiratory problems or apnea and not consuming opiates
Not having cognitive disorders or dimentia
Age between 18 to 60
Exclusion Criteria
Cessation of therapy
Consuming other hypnotic drugs otherwise the ones ordered in this study
Manifestation of adverse drug reaction during the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep quality. Timepoint: Measurements will be taken at the beginning of the study, after the end of treatment, one month and three months after treatment (4 times). Method of measurement: The instruments used to examine patients will be a researcher-made demographic questionnaire and the Petersburg Sleep Quality index Questionnaire and Epworth Questionnaire.
- Secondary Outcome Measures
Name Time Method