The effectiveness of child-centered mindfulness on emotion regulation, cognitive flexibility, and anxiety and depression levels in children with diabetes
Determining the effectiveness of child-centered mindfulness on emotion regulation, cognitive flexibility and levels of anxiety and depression in children with diabetes
Design
The clinical trial has two control and experimental groups, which are randomly selected in the groups of this location.
Settings and conduct
The experimental groups will be treated with mindfulness; But the control group does not receive any intervention. Both the experimental group and the control group are measured twice (pre-test-post-test) separately. The statistical population will be all children with type 2 diabetes in Shiraz city. A 90-minute intervention session and an introduction session will be held weekly before the research, in person with the children and parents of the sample group.
Participants/Inclusion and exclusion criteria
All children with type 2 diabetes with a definite diagnosis from a doctor who have been prescribed insulin injections and are between 10 and 12 years old.
Intervention groups
Debra Burdick's child-centered mindfulness intervention program will be taught and performed in 10 90-minute sessions for the experimental group (15 people) and the control group will not receive any training or intervention before starting the intervention of both groups in terms of variables. Research will be evaluated by questionnaires
The effectiveness of child-centered mindfulness on emotion regulation, cognitive flexibility, and anxiety and depression levels in children with diabetes
Public title
The effectiveness of child-centered mindfulness on emotion regulation, cognitive flexibility, and anxiety and depression levels in children with diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All children with type 2 diabetes
Exclusion criteria:
Outside the age group of 10 to 12 years
Age
From 10 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 30 people are selected according to similar research, in an accessible way. Then random replacement is done by lottery method (one number will be assigned to each of the sampled people). We write down the numbers on paper, fold them and put them in a container. We mix and stir the papers completely. Then we take out the papers one by one and put one number in the first group and one number in the second group.Then random application will be done. In this way, one group is known as "control group" and the other group is known as "intervention group". The lottery will be done by putting the two groups obtained from the previous step (random replacement step) into two separate envelopes and placing them in a container. Then we randomly take one envelope out of the container and assign it to the "intervention group" and the other envelope to the "control group". Research data are analyzed using SPSS version 21 statistical package software in social sciences.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee
Street address
University blvd
City
Arsanjan
Province
Fars
Postal code
7133864396
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.IAU.A.REC.1401.015
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
بیماریهای
ICD-10 code description
بیماریهای طبی
Primary outcomes
1
Description
"Determining the effectiveness of child-centered mindfulness on anxiety" anxiety score in the Spence anxiety questionnaire and obtaining a score higher than 60 in this questionnaire
Timepoint
Evaluation of the anxiety score before the intervention and after 10 sessions of mindfulness training
Method of measurement
The way to measure the outcome variable is through the Spence Anxiety Questionnaire.
2
Description
"Determining the effectiveness of child-centered mindfulness on depression" depression score in Maria's children's depression questionnaire and obtaining a score higher than 27 in this questionnaire
Timepoint
Assessment of depression score before the intervention and after 10 sessions of mindfulness training
Method of measurement
The method of measuring the outcome variable is through the Maria Kovacs Children's Depression Questionnaire.
3
Description
"Determining the effectiveness of child-centered mindfulness on emotion regulation" The emotion regulation score in the cognitive regulation of emotion questionnaire by Garnofsky and obtaining a score higher than 50 in this questionnaire
Timepoint
Evaluation of the emotion regulation score before the intervention and after 10 sessions of mindfulness training
Method of measurement
The way to measure the outcome variable is through the Garnofsky emotion regulation questionnaire.
4
Description
"Determining the effectiveness of child-centered mindfulness on cognitive flexibility" cognitive flexibility score in Dennis and Vanderwaal's cognitive flexibility questionnaire and obtaining a score of less than 20 in this questionnaire
Timepoint
Evaluation of the cognitive flexibility score before the intervention and after 10 sessions of mindfulness training
Method of measurement
The method of measuring the outcome variable is through Dennis and Vanderwaal's cognitive flexibility questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will undergo child-centered mindfulness therapy for 10 sessions of 45 minutes based on a certain schedule in the sessions determined according to the headings of the educational package taken from Debra Burdick's method of child and adolescent mindfulness.
Category
Rehabilitation
2
Description
Control group: This group will not receive any intervention and will only be evaluated based on research variables before the intervention and after the intervention for the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Shiraz Hospital
Full name of responsible person
Dr. Sara Deh Gorgi
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9080
Email
rcpsych1@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arsanjan Islamic Azad University
Full name of responsible person
Dr. Ali Mohammad Rezaei
Street address
University blvd
City
Arsanjan
Province
Fars
Postal code
7376153161
Phone
+98 71 4352 3908
Email
Afsane1@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arsanjan 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sara Deh Gorgi
Position
Child and adolescent psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hafez Hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
rcpsych1@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arsanjan Islamic Azad University
Full name of responsible person
Afsaneh nouri
Position
Master's student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ghasedasht
City
Shiraz
Province
Fars
Postal code
7133864396
Phone
+98 71 3233 6408
Email
Afsane1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arsanjan Islamic Azad University
Full name of responsible person
Afsaneh nouri
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
ghasedasht
City
Shiraz
Province
Fars
Postal code
7133864396
Phone
+98 71 3233 6804
Email
Afsane1@yahoo.com
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