1.Comparison of the effects of clonidine and melatonin in the treatment of insomnia in 6 to 12 years old children with anxiety disorders
2. Determination of the effectiveness of clonidine in comparison with placebo, at zero, 4 weeks and 6 weeks after the start of the intervention in the treatment of insomnia in 6 to 12 years old children with anxiety disorder
3.Determining the effectiveness of melatonin in comparison with placebo, at zero, 4 weeks and 6 weeks after the start of the intervention in the treatment of insomnia in 6 to 12 years old children with anxiety disorders.
4.Comparison of the effectiveness of clonidine and melatonin at zero, 4 weeks and 6 weeks after the start of the intervention in the treatment of insomnia in 6 to 12 years old children with anxiety disorders
Design
randomized clinical trial with group control
double blinded
randomized with excel
sample size:72
Settings and conduct
double blinded
sleep disorder due to anxiety disorder
sina hospital
Coding of the intervention groups was done by one of the clinic's experts who is not part of the planning process, and the research group will be unaware of the coding until the end of the research.
Participants/Inclusion and exclusion criteria
inclusive criteria:
Parents' consent for participating in the study
6 to 12 years old
Suffering from one of the types of anxiety disorders
Exclusion criteria:
sever adverse effects
Physical illness
Intervention groups
intervention group 1 : 24 children with 6 to 12 years old with insomnia due to anxiety disorders, melatonin, CSHQ
intervention group 2 : 24 children with 6 to 12 years old with insomnia due to anxiety disorders, clonidine , CSHQ
control group: 24 children with 6 to 12 years old with insomnia due to anxiety disorders, placebo , CSHQ
Main outcome variables
Sleep quality of children with anxiety disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220820055756N1
Registration date:2022-10-16, 1401/07/24
Registration timing:registered_while_recruiting
Last update:2022-10-16, 1401/07/24
Update count:0
Registration date
2022-10-16, 1401/07/24
Registrant information
Name
Ali Jalalifiroozkoohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 9765
Email address
a.jalalifiroozkoohi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clonidine and melatonin for treating insomnia in children 6 to12 years old with anxiety disorder
Public title
Comparison of clonidine and melatonin for treating insomnia in children 6 to12 years old with anxiety disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
parent consent for participating in study
6 to12 years old children
suffering from atleast one of the anxiety disorders
sleep disorder due to anxiety disorders
Exclusion criteria:
parents dissatisfaction with participating
suffering from physical disease
using other sedative and hypnotic drugs except clonidine and melatonin
history of allergy to clonidine and melatonin
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: In this study, volunteers will be assigned to three groups by simple randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in a double-blind manner.The drugs used will be delivered to the mentioned patients in a similar form and appearance. Coding of the intervention groups was done by one of the clinic's experts, who is not part of the research program , and the research group will not be aware of the coding until the end of the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnic committee of Hamedan University of Medical Sciences
Street address
Sina Hospital Mirzade Eshghi Street
City
Hamedan
Province
Hamadan
Postal code
4874165168
Approval date
2022-08-21, 1401/05/30
Ethics committee reference number
IR.UMSHA.REC.1401.460
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
quality of sleep
Timepoint
week4 and 6
Method of measurement
children's sleep questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:24 children between 6 to 12 years old with sleep disorders due to anxiety disorders who will be treated with melatonin (3 mg). For first three day melatonin will be administrated by 1/4 of a pill .after these days it will be increased to 1/2 of a pill . After one week the mentioned drug will be increased to a pill .It should be noted that after 4 and 6 week the quality of sleep willl be measured by CSHQ.
Category
Treatment - Drugs
2
Description
Intervention group:24 children between 6 to 12 years old with sleep disorders due to anxiety disorders who will be treated with clonidine (0.2 mg). For first three day clonidine will be administrated by 1/4 of a pill .after these days it will be increased to 1/2 of a pill . After one week the mentioned drug will be increased to a pill .It should be noted that after 4 and 6 week the quality of sleep willl be measured by CSHQ.
Category
Treatment - Drugs
3
Description
Control group:24 children between 6 to 12 years old with sleep disorders due to anxiety disorders who will be treated with palcebo. For first three day placebo will be administrated by 1/4 of a pill .After these days it will be increased to 1/2 of a pill . After one week the placebo will be increased to a pill .It should be noted that after 4 and 6 week the quality of sleep willl be measured by CSHQ.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Farschian (Sina) Hospital
Full name of responsible person
Dr Helen Behmanesh
Street address
Mirzade Eshghi Street
City
Hamedan
Province
Hamadan
Postal code
4874165168
Phone
+98 81 3822 9765
Email
a.jalalifiroozkoohi@edu.umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokouhi
Street address
4th flour,Setad building,Hamedan Medical University,Shahid Fahmide Street,Pajohesh Squar
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
Info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Helen Behmanesh
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Sina hospital / Mirzade Eshghi Street
City
Hamedan
Province
Hamadan
Postal code
4874165168
Phone
009838274191
Email
behmanesh.helen@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Helen Behmanesh
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Sina hospital ,Mirzadeeshghi Street
City
Hamedan
Province
Hamadan
Postal code
4874165168
Phone
+98 81 3827 4191
Email
behmanesh.helen@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Jallali Firouzkohi
Position
resident of psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Sina hospital ,Mirzade Eshghi Street
City
Hamedan
Province
Hamadan
Postal code
4874165168
Phone
+98 81 3827 4191
Email
a.jalalifiroozkoohi@edu.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
because the information is collected confidentially from the patients and the information is generally valuable.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
quality of sleep during the use of mentioned drug
When the data will become available and for how long
6 month after publishing
To whom data/document is available
all researcher
Under which criteria data/document could be used
after finishing the project it will publish as an article
From where data/document is obtainable
dr helen behmanesh
What processes are involved for a request to access data/document
after finishing the project it will publish as an article