Comparison of the Effectiveness of Group Self-Care Education With Play-Therapy in Adherence To Treatment And Quality Of Life In Children With type 1 Diabetes
Comparison of the Effectiveness of Group Self-Care Education With Play-Therapy in Adherence To Treatment And Quality Of Life In Children With type 1 Diabetes
Design
Clinical trial;with a control group;Randomised
Settings and conduct
Individuals will be randomly assigned to three groups: skills training, play therapy, and control.
Psychological skills that are taught in this study in an 8-session protocol as a group to children in the first group, including: training, cognition of emotions, identification, physical reactions to anxiety, relaxation training, identification of anxiety self-talk. Challenging and thinking training, problem-solving skills training, self-reward based on effort and performance, social skills training and courage. Diabetes-related physical self-care behaviors are also taught to the first group...in this study, play therapy in an 8-session protocol is performed in groups with children in the second group. Shakiba child play therapy consists of two stages: play alarm therapy and watchtower play therapy. Teaches children through games. The game is played in groups of 5 people.
The third group, which is the control group, does not receive any intervention
Participants/Inclusion and exclusion criteria
Children 8 to 11 years old with type 1 diabetes;No emotional or behavioral problems.Not receiving psychotherapy for the past 6 months
Intervention groups
Self-care education;Play-therapy;control Group
Main outcome variables
Improving the quality of life and adherence to treatment in children with type 1 diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040974N3
Registration date:2020-09-09, 1399/06/19
Registration timing:prospective
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Fatemeh Zargar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
f.zargar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Group Self-Care Education With Play-Therapy in Adherence To Treatment And Quality Of Life In Children With type 1 Diabetes
Public title
Effect Of Education With Play-Therapy In Treatment Of Children With type 1 Diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Children With type 1 diabetes
Exclusion criteria:
The child does not have emotional-behavioral problems
Age
From 8 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization;Individual;Random Number Table;Central Randomization.
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 Isfahan University of Medical Sciences
Street address
Isfahan University Of Medical Sciences;Hezarjarib Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.MUI.MED.REC.1399.255
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Adherence to treatment in children with diabetes.Quality of life in children with diabetes.
Timepoint
Before intervention;after intervention
Method of measurement
Quality of life questionnaire-kidscreen
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-care group education.A mental and physical care education program is offered by a psychologist in 8 one-hour sessions.In these sessions, emotion recognition and control skills, relaxation skills, proper nutrition principles of insulin injection and coping with anxiety related to diabetes are trained.
Category
Treatment - Other
2
Description
Intervention group: Play_Therapy.A treatment game that offers tips on diabetes self-care is played with this group in 8 one-hour sessions.
Category
Treatment - Other
3
Description
Control group: Control
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Naimeh Haghshenas
Street address
No. 8, intersection of Hashtbehesht Street, Ostandari Avenue
City
Esfahan
Province
Isfehan
Postal code
8199888945
Phone
+98 31 3222 2127
Email
naimeh.a.h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
DR Javanmard Haghjooy Shaghayegh
Street address
Hezarjarib Ave;Isfahan University Of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 8032
Email
Jazb@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Aileen Salmani
Position
masters
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hezarjarib Ave;Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8032
Email
ailin.salmani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ailin Salmani
Position
Masters
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.322;Seyed Morteza 12 Ave ;Moalem Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188835563
Phone
+98 51 3608 1897
Email
ailin.salmani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ailin Salmani
Position
Masters
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.322;Seyed Morteza 12 Ave;Moalem Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188835563
Phone
+98 51 3608 1897
Email
ailin.salmani@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