Determining the effect of education based on acceptance and commitment in mothers on sleep quality and feeding pattern of primary school children in Gorgan city in 1402-1403
Design
Clinical trial with control group, with parallel groups, unblinded, randomized, on 100 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The purpose of this research is to determine the impact of education based on commitment and acceptance on the quality of sleep and nutrition patterns of school-aged children in primary schools of Gorgan city. The researcher will refer to the officials of elementary schools in Gorgan city and the favorable opinion of the officials and parents of the children will be obtained to conduct the research. After visiting the school, the researcher is selected from among the people who have files and meet the study entry criteria.
Participants/Inclusion and exclusion criteria
Entry requirements:
The interest and willingness of mothers of elementary school children to participate in the research
Mothers with children aged 7 to 12 years
Absence of digestive disease and sleep disorders in children
Non-entry conditions:
Child's unwillingness to participate in research
Participation in a similar educational program that is concurrent with the implementation of the intervention
Intervention groups
The intervention group of the effectiveness of education based on acceptance and commitment
Main outcome variables
Sleep quality and nutritional pattern
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240721062488N1
Registration date:2024-08-11, 1403/05/21
Registration timing:prospective
Last update:2024-08-11, 1403/05/21
Update count:0
Registration date
2024-08-11, 1403/05/21
Registrant information
Name
Atefeh Tajari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3333 3333
Email address
atefe.tajari76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-10-02, 1403/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on commitment and acceptance of mothers on sleep quality and feeding pattern of primary school children
Public title
The effect of training based on commitment and acceptance of mother s on sleep quality and dietery pattern of primary school children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The interest and willingness of mothers of elementary school children to participate in the research
Mothers with children aged 7 to 12 years
Absence of digestive disease and sleep disorder in children
Exclusion criteria:
Child's unwillingness to participate in research
Participation in a similar educational program that is concurrent with the implementation of the intervention
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two control and intervention groups using a 2-way block method (using sealed opaque envelopes). In this way, 40 envelopes will contain 2 AB codes (code A for the education intervention based on acceptance and commitment, code B for the control group ) will be prepared. From each of these letters placed together, envelopes will be prepared and people will be randomly selected based on the order of letters in the envelope Control will be assigned.
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 Islamic Azad University - Tonekabon Branch
Street address
Mazandaran-Tankaben-Km 3 Chalus Road-Waliabad-Tankaben Islamic Azad University Complex-Dr. Miftah Building-Medical Faculty
Intervention group: The group will receive the treatment test based on commitment and acceptance during 8 sessions, 2 days a week. The duration of each session is 90 minutes, of which 45 minutes will be taught in relation to sleep quality and another 45 minutes in relation to nutrition pattern. Training is based on commitment and acceptance therapy. The educational intervention is implemented by the researcher. The training content of the test group is based on the up-to-date resources of the training protocol of treatment sessions based on the commitment and acceptance book of Hayes acceptance and commitment book. Strossal and Wilson, which is approved by the Ministry of Health, and its content validity will be approved by the supervisor. which is implemented by the method of lectures, questions and answers, presentation of pamphlets, educational booklets and group discussions.
Category
Rehabilitation
2
Description
Control group: It does not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini School
Full name of responsible person
Abbas Abbasi
Street address
Kashani Blvd., East Bahman Street, Seventh Park Street
City
Gorgan
Province
Golestan
Postal code
0000000000
Phone
+98 17 3324 2234
Email
atefe.tajari76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sakineh Farhadi
Street address
Daneshgah Boulevard - Islamic Azad University, Aliabad Katul branch
City
Aliabad katool
Province
Golestan
Postal code
4941793451
Phone
+98 17 3423 7933
Email
s-farhadi@aliabadiau.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
Private
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
Atefeh Tajari
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan province - Aliabad Katul city - University Blvd - Islamic Azad University, Aliabad Katul branch
City
Alibad katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Email
morteza.sampad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Golbahar Akhundzadeh
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan province - Aliabad Katul city - University Blvd - Islamic Azad University, Aliabad Katul branch
City
Aliabad katool
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 5673
Email
g.akhondzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atefeh Tajari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad university of aliabad branch
City
Aliabad katool
Province
Golestan
Postal code
1111111111
Phone
+98 17 3333 3333
Fax
Email
atefe.tajari76@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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available