This study aims to investigate the effect of doogh as an accessible dairy product on improving students’ sleep conditions.
Design
Two arm parallel group randomised controlled trial, with 20 subjects in each two groups
Settings and conduct
Researcher, questioner and who that analyst data will be blinded from subjects allocation in each intervention or control group
Participants/Inclusion and exclusion criteria
The main inclusion criteria: female, single, age between 18 and 30 years with no using anti-depressants.
Exclusion criteria: lack of proper and regular use of doogh and water
Intervention groups
Intervention group: Doogh, 250 milliliter one hour before sleep
Control group: Water, 250 milliliter one hour before sleep
Main outcome variables
Sleep quality
Sleep length at night
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170919036274N2
Registration date:2018-06-03, 1397/03/13
Registration timing:registered_while_recruiting
Last update:2018-06-03, 1397/03/13
Update count:0
Registration date
2018-06-03, 1397/03/13
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
rajabi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of dough consumption on sleep disorders among student who living in female dormitories of Ahvaz Jundishapour University of Medical Sciences
Public title
Effect of doogh on improving sleep disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
females between the age of 18 to 30 years
University Students
With no using anti-depressants
With no mental disorders
Exclusion criteria:
incomplete questionnaire
lack of proper and regular use of doogh and water
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Simple
Unit of randomization: Individual
Tools used in randomization: Table of random number
Blinding (investigator's opinion)
Not blinded
Blinding description
Researcher, questioner, and data analyst, remain ineligible for each participant in the intervention or control group, until the end of the analysis of the results, .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand street, Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.AJUMS.REC.1396.1030
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
Morning tiredness
Timepoint
The beginning and the end of the intervention
Method of measurement
questionnaire
2
Description
Sleep Latency
Timepoint
The beginning and the end of the intervention
Method of measurement
questionnaire
3
Description
Day dysfunction due to sleepiness
Timepoint
The beginning and the end of the intervention
Method of measurement
questionnaire
4
Description
Overall sleep quality
Timepoint
The beginning and the end of the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: diet controling, 300 ml of doogh an hour before bedtime for three weeks
Category
Other
2
Description
diet controlling,a glass of water an hour before bedtime for 3 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Boostan dormitory
Full name of responsible person
Mahtab Rajabi Jourshari
Street address
Boostan dormitory, front of Bargh township, Karegar square, Boostan
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 61 3383 7317
Email
mahtab.Rajabi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand street, Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Phone
+98 61 3373 8317
Email
mahtab.Rajabi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahavz Jundishapur University of Medical Sciences
Full name of responsible person
Mahtab Rajabi Jourshari
Position
Bachelor of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand street, Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Email
mahtab.Rajabi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahavz Jundishapur University of Medical Sciences
Full name of responsible person
Sima Jafarirad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand street, Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Email
sjafarirad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahavz Jundishapur University of Medical Sciences
Full name of responsible person
Mahtab Rajabi Jourshari
Position
Bachelor of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand street, Farvardin Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Email
mahtab.Rajabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting one year after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
For Meta-analysis studies
From where data/document is obtainable
Completing a request form and sending to the Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
What processes are involved for a request to access data/document
Completing a request form and sending to the Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences via regular mail