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melatonin and sleep quality

The effect of melatonin on the sleep quality of patients with chronic pelvic pain caused by endometriosis, a triple-blind randomized controlled trial study in the provider unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171209037794N4
Enrollment
80
Registered
2023-07-07
Start date
2023-07-16
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis. Endometriosis

Interventions

Intervention 1: Intervention group: patients will receive 5 mg melatonin tablet once a day for 2 months. Intervention 2: Control group: patients will receive placebo once a day for 2 months.

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Sleep quality. Timepoint: Before and 2 months after intervention. Method of measurement: PSQI-19 questionnaire.

Secondary

MeasureTime frame
Pelvic pain. Timepoint: Before and two months after the intervention. Method of measurement: VAS score.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactparvaneh mirabi

Babol University of Medical Sciences

parvaneh_mirabi@yahoo.com+98 11 3219 0558

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026