Overall Objective:
Determine the effect of white noise on the sleep quality of children aged one to three years
Special Purpose:
1. Determine the quality of sleep in children 1 to 3 years before intervention in the intervention group
2. Determine the quality of sleep in children aged 1 to 3 years after intervention in the intervention group
Design
Quasi-experimental clinical trial with intervention group without control group, randomized, lottery type
Settings and conduct
The intervention method is to refer to the kindergarten and the importance of sleep and quality of sleep and its effective factors are explained in person. If they wish to enter the Sleep quality questionnaire before the intervention, they are given to complete and then to The intervention group delivers audio files, which for 10 nights the white noise is distributed to the child while the baby is sleeping for the child and after the intervention the questionnaire is returned to complete again.
Participants/Inclusion and exclusion criteria
Criteria for entering the study
1. The age of the child is one to three years
2. Pass at least three months from the time you arrive at the kindergarten
3. At least 5 days per week in kindergarten
4. The child will live with his real mother
5. Ability to listen to the medical records in kindergarten
6. The absence of psychiatric and neurological disorders according to the medical records in kindergarten
7. Do not use drugs that affect sleep, including hypnotics and psychosocial drugs
8. Not having breathing problems and allergies
9. The existence of informed consent
Exit criteria
1. Unwilling to continue the scheme
2. Occurrence of a medical disorder or trauma at the time of study
Intervention groups
All 1-3 year old children are kept in kindergartens in Zabul city, including 24 kindergartens, 136 children from 1 to 3 years of age
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190704044096N1
Registration date:2019-07-16, 1398/04/25
Registration timing:prospective
Last update:2019-07-16, 1398/04/25
Update count:0
Registration date
2019-07-16, 1398/04/25
Registrant information
Name
Zahra Mosalman Kahkha Jaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 2184
Email address
zahra.mosalman2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of White Voice on the Quality of Sleeping Children in One to Three Years
Public title
Effect of White Voice on the Quality of Sleeping Children in One to Three Years
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of a child is one to three years
Passing for at least three months after admission to kindergarten
At least 5 days a week in kindergarten
The child lives with his real mother
Listening ability according to the medical records in kindergarten
Not having psychiatric and neurological disorders according to the medical records in kindergarten
Not using sleep medications, including hypnotics and psychosocial drugs
Not having breathing problems and allergies
Conscious Consciousness
Exclusion criteria:
Unwilling to continue the scheme
Occurrence of a medical disorder or trauma at the time of study
Age
From 1 year old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples will be chosen randomly based on the criteria for entering the study. For grouping, random sampling will be done by lottery method that will be selected in the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biological Research, Islamic Azad University, Tehran, Iran
Street address
Islamic Azad University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1234567890
Approval date
2018-09-03, 1397/06/12
Ethics committee reference number
IR.IAU.TMU.REC.1397.102
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ُُSleep Quality
Timepoint
Before the intervention and 7 days after the intervention began
Method of measurement
The Children’s Sleep Habits Questionnaire Abbreviated
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children one to three years old
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kindergartens in Zabol city
Full name of responsible person
Zahra Mosalman
Street address
Ferdosi
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
1234567890
Phone
+98 21 6690 2184
Email
zahra.mosalman2016@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hejazi
Street address
Sohanak
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2200 6660
Email
info@nursing.iautmu.ac.ir
Web page address
http://nursing.iautmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Zahra Mosalman
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Eskandari Ave.
City
Tehran
Province
Tehran
Postal code
1419753841
Phone
+98 21 6690 2184
Email
zahra.mosalman2016@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Mosalman
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Eskandari Ave.
City
Tehran
Province
Tehran
Postal code
1419753841
Phone
+98 21 6690 2184
Email
zahra.mosalman2016@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Mosalman
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Eskandari Ave.
City
Tehran
Province
Tehran
Postal code
1419753841
Phone
+98 21 6690 2184
Email
zahra.mosalman2016@gmail.com
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