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

Studying the effect of melatonin on sleep quality and anxiety in hemodialysis patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251127068128N2

Enrollment

Registered

2026-01-30

Start date

2026-02-04

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Condition 1: End-stage chronic renal failure treated with hemodialysis. Condition 2: Sleep quality disorders in hemodialysis patients. Condition 3: Sleep quality disorders in hemodialysis patients. End stage renal disease Insomnia Generalized anxiety disorder

Interventions

Intervention 1: Intervention group: The patients in this group include 28 people who take 3 mg of melatonin every night 30 minutes before bedtime. The treatment period is 6 weeks and the aim of this i

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years and older At least 6 months of hemodialysis history PSQI score above 5 (indicating poor sleep quality) GAD-7 score greater than 5 (indicating the presence of anxiety) Not taking melatonin or other sleep medications in the past 3 months

Exclusion criteria

Exclusion criteria: Having severe neurological disorders or psychiatric illnesses under treatment Taking medications that affect melatonin metabolism (such as fluvoxamine) Uncontrolled heart failure Active malignant diseases Severe infections Need for emergency or surgical interventions during the study PSQI score less than 5 or GAD-7 score less than 5 during the study

Design outcomes

Primary

Measure	Time frame
Sleep quality. Timepoint: At baseline and 6 weeks after intervention. Method of measurement: The questionnaire consists of 9 questions and assesses 7 components of sleep quality. The total score ranges from 0 to 21; a higher score indicates poorer sleep quality. A score greater than 5 indicates sleep disturbance.;Anxiety Severity. Timepoint: Before the start of the intervention 6 weeks after the start of the intervention. Method of measurement: The questionnaire consists of 7 questions with a 4-point Likert scale (0 to 3) and the total score ranges from 0 to 21. Higher scores indicate more severe anxiety. A score of more than 5 indicates the presence of anxiety.	—

Measure

Time frame

Sleep quality. Timepoint: At baseline and 6 weeks after intervention. Method of measurement: The questionnaire consists of 9 questions and assesses 7 components of sleep quality. The total score ranges from 0 to 21; a higher score indicates poorer sleep quality. A score greater than 5 indicates sleep disturbance.;Anxiety Severity. Timepoint: Before the start of the intervention 6 weeks after the start of the intervention. Method of measurement: The questionnaire consists of 7 questions with a 4-point Likert scale (0 to 3) and the total score ranges from 0 to 21. Higher scores indicate more severe anxiety. A score of more than 5 indicates the presence of anxiety.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahla Ahmadi Halili

Ahvaz University of Medical Sciences

ahmadihalili-sh@ajums.ac.ir0612222922

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026