The aim of this study was to investigate the effect of melatonin drug therapy on sleep quality and anxiety levels in patients and compare it with the control group. changes in sleep quality using the Pittsburgh Sleep Quality Questionnaire (PSQI) and anxiety levels using the GAD-7 questionnaire will be evaluated and analyzed before and after drug intervention.
Design
The present study is a controlled clinical trial with a two-group design (intervention and control) and pre- and post-intervention evaluation, which will be conducted prospectively.
Settings and conduct
It will be conducted voluntarily and with informed consent from the participants. The study will be conducted in the dialysis ward of Imam and Golestan Hospital. All participant information will be kept confidential and no identifying information will be recorded.
Participants/Inclusion and exclusion criteria
Age 18 years and older, at least 6 months of hemodialysis, PSQI score greater than 5 (indicating poor sleep quality), GAD-7 score greater than 5 (indicating anxiety), no use of melatonin or other sleeping pills in the past 3 months
Severe neurological disorders or psychiatric illnesses under treatment, use of 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
Intervention groups
Intervention group: receiving melatonin according to the instructions specified in the study protocol. Control group: receiving usual treatment (without melatonin). Both groups will be homogenized in terms of demographic variables and study entry conditions.
Main outcome variables
Sleep quality based on the Pittsburgh Sleep Quality Questionnaire (PSQI) total score Anxiety level based on the Generalized Anxiety Disorder (GAD-7) score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251127068128N2
Registration date:2026-01-30, 1404/11/10
Registration timing:prospective
Last update:2026-01-30, 1404/11/10
Update count:0
Registration date
2026-01-30, 1404/11/10
Registrant information
Name
Shahla Ahmadi Halili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 681 6124
Email address
ahmadihalili-sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-04, 1404/11/15
Expected recruitment end date
2026-10-07, 1405/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of melatonin on sleep quality and anxiety in hemodialysis patients
Public title
The effect of melatonin on sleep quality and anxiety in hemodialysis patients.
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
After meeting the inclusion and exclusion criteria, eligible patients are randomly assigned to two groups: intervention (receiving melatonin) and control (without drug intervention) in a 1:1 ratio using a simple random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences، Koi Golestan، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2026-01-10, 1404/10/20
Ethics committee reference number
IR.AJUMS.REC.1404.556
Health conditions studied
1
Description of health condition studied
End-stage chronic renal failure treated with hemodialysis
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
2
Description of health condition studied
Sleep quality disorders in hemodialysis patients
ICD-10 code
G47.0
ICD-10 code description
Insomnia
3
Description of health condition studied
Sleep quality disorders in hemodialysis patients
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
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.
2
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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 intervention is to examine the effects of melatonin on sleep quality in hemodialysis patients.
Category
Treatment - Drugs
2
Description
Control group: The patients in this group, which consists of 28 people, will not receive any drug intervention. This group is intended to examine the effect of melatonin compared to the natural sleep and anxiety patterns of hemodialysis patients.Initially, patients will be given a sleep disorder and anxiety disorder questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital., Dialysis Unit
Full name of responsible person
Shahla Ahmadi Halili
Street address
ers from Imam Khomeini Hospital., Dialysis unit
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 681 6124
Email
ahmadihalili-sh@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Golestan hospital., Dialysis unit
Full name of responsible person
Shahla Ahmadi Halili
Street address
Koi golestan., Golestan hospital., Dialysis unit
City
Ahvaz
Province
Khouzestan
Postal code
6135733117
Phone
+98 916 681 6124
Email
ahmadihalili-sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdollah Rafiei
Street address
24 metery street, East sahely highway, Ahvaz
City
َAhvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 681 6124
Email
ahmadihalili-sh@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahla Ahmadi Halili
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan St., 24 meters from Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
0612222922
Email
ahmadihalili-sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahla Ahmadi Halili
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan., 24 meters., imam khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 681 6124
Fax
Email
ahmadihalili-sh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahla Ahmadi Halili
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan., 24 meters., imam khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 681 6124
Fax
Email
ahmadihalili-sh@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available