MedPath

melatonin and sleep quality

Phase 3
Recruiting
Conditions
Endometriosis.
Endometriosis
Registration Number
IRCT20171209037794N4
Lead Sponsor
Babol University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
80
Inclusion Criteria

The eligibility of each included patients will be confirmed by the gynecologist. Subjects eligible for the study must meet all of the following criteria at randomization: •18- 45 years of age, who had complained of endometriosis with EACPP, and Sleep disturbances based on PSQI questionnaire (score = 5). •No history of surgical or medical treatments for infertility. •Not smoking, drinking alcohol, and addiction to substance. •Lack of systemic illness diseases, such as diabetes, blood pressure, seizures

Exclusion Criteria

•continuous use of sleeping pills, anticoagulants and anticonvulsants •women treated with antidepressants •use of stimulants or hypnotics or anti-anxiety medications •recent diagnosis of mood disorders or neuropsychiatric symptoms (within 8 weeks) •pregnancy or breastfeeding •known hypersensitivity to melatonin •If the patient does not want to continue to participation •Ongoing or previous pharmacologically treated depression or bipolar disorder •Work involving nightshifts

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sleep quality. Timepoint: Before and 2 months after intervention. Method of measurement: PSQI-19 questionnaire.
Secondary Outcome Measures
NameTimeMethod
Pelvic pain. Timepoint: Before and two months after the intervention. Method of measurement: VAS score.
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