The Effect of Melatonin on sleep quality and cognitive function of hemodialysis patients

The Effect of Melatonin on Sleep Quality and Cognitive Function of Hemodialysis Patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211030052917N1

Enrollment

102

Registered

2021-12-14

Start date

2021-11-22

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

The effect of melatonin on sleep quality and cognitive function in hemodialysis patients.

Interventions

Intervention 1: Intervention group: Patients in the intervention Group will receive 3 mg of Melatonin (Razak Company, 3 mg per tablet) at Night, half an hour before bedtime for 6 Weeks. The questionna

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: People 18 years and older The patient should not involved in any other research project The patient can give informed consent Hemodialysis for more than 6 months The patient has a Pittsburgh sleep quality index score higher than 5 The patient has a Montreal cognitive function index score lower than 26 The patient has adequate vision and hearing The patient has normal thyroid tests

Exclusion criteria

Exclusion criteria: The patient has already taken melatonin The patient has a history of taking sleeping pills The patient has a history of taking any drugs The patient has an active infection The patient is pregnant or breastfeeding The patient has uncontrolled diabetes The patient has dementia The patient has liver disorders The patient has cerebrovascular disorders The patient needs immediately Intervention for Hospitalization and surgery The patient has heart failure The patient has iron deficiency anemia Patients taking anti-anxiety or hypnotic drugs due to neuropsychiatric disorders

Design outcomes

Primary

Measure	Time frame
Patients' sleep quality Score on the Pittsburgh Sleep Quality Assessment Tool. Timepoint: Measurement of Sleep Quality at the beginning of the Study (before the intervention) and immediately after the intervention in the intervention Group and Control Group. Method of measurement: Pittsburgh Sleep Quality Questionnaire.;Patients' cognitive Function score in the Montreal Cognitive Assessment Tool. Timepoint: Measurement of cognitive Functions at the beginning of the Study (before the intervention) and immediately after the intervention in the intervention Group and Control Group. Method of measurement: Montreal Cognitive Assessment Questionnaire.	—

Measure

Time frame

Patients' sleep quality Score on the Pittsburgh Sleep Quality Assessment Tool. Timepoint: Measurement of Sleep Quality at the beginning of the Study (before the intervention) and immediately after the intervention in the intervention Group and Control Group. Method of measurement: Pittsburgh Sleep Quality Questionnaire.;Patients' cognitive Function score in the Montreal Cognitive Assessment Tool. Timepoint: Measurement of cognitive Functions at the beginning of the Study (before the intervention) and immediately after the intervention in the intervention Group and Control Group. Method of measurement: Montreal Cognitive Assessment Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzie Salehi Hikoui

Mazandaran University of Medical Sciences

marziesalehi12@gmai.com+98 11 3323 6086

Outcome results

None listed

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