Protocol summary

Study aim
Determining the effect of resilience training on the level of quality of life and self-esteem of mothers of diabetic children in Gonbad Kavus and Gorgan cities in 1401
Design
Sampling in this research will be random and 50 mothers will be divided into two intervention and control groups, each group will contain 25 people, using a random number table. Both groups will fill two questionnaires of quality of life and self-esteem as a pre-test. The experimental group will undergo family resilience training for 9 sessions of 90 minutes and 2 sessions per week in groups of 5 people. After applying the intervention to the intervention group, both the intervention and control groups will complete the quality of life and self-esteem questionnaire as a post-test and then the data will be analyzed.
Settings and conduct
This research is of the classical experimental type (two groups pre-test - post-test) with two groups of test and control. This study will be conducted experimentally in parallel groups in Taleghani diabetes clinic and social security and private clinics in Gonbad and Gorgan cities in 1401. To carry out the research, first the necessary permits will be obtained from the Ethics Committee of Taleghani Clinic in Gonbad and Tamin Hospital and private clinics in Gonbad and Gorgan.
Participants/Inclusion and exclusion criteria
1. Mothers with at least one diabetic child between the ages of 7 and 13. 2. Literate 3. Willingness to participate in meetings 4. Having physical health.
Intervention groups
Content of training sessions included 1: Getting to know the group members. 2: explanations to mothers 3: Courage and encouragement. 4: Spirituality. the faith. 5: mutual support 6: a field of emotions 7: Focus on goals. 8: Cultivating self-confidence. 9: Summary
Main outcome variables
Quality of life - self-esteem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230430058034N1
Registration date: 2023-07-18, 1402/04/27
Registration timing: retrospective

Last update: 2023-07-18, 1402/04/27
Update count: 0
Registration date
2023-07-18, 1402/04/27
Registrant information
Name
Aynaz Agh
Name of organization / entity
The Univercity of Aliabad
Country
Iran (Islamic Republic of)
Phone
+98 17 3333 2261
Email address
aynazagh123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of the resilience training intervention program on quality of life and self-esteem of mothers of diabetic children
Public title
Effectiveness of the resilience training intervention program on quality of life and self-esteem of mothers of diabetic children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1. Mothers who have at least one diabetic child between the ages of 7 and 13. 2. Have a level of literacy in reading and writing. 3. Have a desire to participate in resilience training sessions. 4. Having physical health, according to their health records and their advisors, and the mothers themselves do not have chronic diseases
Exclusion criteria:
The existence of mental illnesses of the child addict parents The long distance of the child's place of residence that they are not able to travel alternately
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The study subjects will be divided into 2 control and intervention groups by using simple randomization method and random number table. First, each person is assigned a number. Then, using the table of random numbers, each selected number is randomly assigned to one of the groups, and this work continues until the number of people in each group is completed. Therefore, the researcher will not have the authority to change the assignment status of people or predict it.
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 aliabad e katool
Street address
No. 237. Rahnamaei St.
City
Gnbad Kavoos
Province
Golestan
Postal code
4971946367
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.IAU.AK.REC.1401.004

Health conditions studied

1

Description of health condition studied
Resilience training
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
quality of life
Timepoint
2 month
Method of measurement
quality of life questionnaire

2

Description
self esteem
Timepoint
2 month
Method of measurement
self esteam cooper questionnaire

Secondary outcomes

1

Description
Quality of life score and self-esteem score
Timepoint
2 month
Method of measurement
1- Cooper Smith Self-Esteem Questionnaire (SEI) 2- SF-36 Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group: In the treatment protocol intervention group, the resilience training intervention, which is based on the protocol adopted from Walsh's family resilience book, will be conducted with 9 treatment sessions and each session will last 90 minutes for 2 months. The training content includes getting to know the members of the group, providing necessary explanations to the mothers about the purpose of training sessions, courage, spirituality, mutual support, emotions, focusing on goals, self-awareness, summarizing and finishing the training given in the field of resilience.
Category
Other

2

Description
Control group: In this group, there is no protocol and the desired samples do their routine work
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mrs. Halima Badakhshan
Street address
Emam St.
City
Gonbad Kavoos
Province
Golestan
Postal code
4979123456
Phone
+98 17 3322 3997
Email
aynazagh123@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Aliabad Katul Azad University
Full name of responsible person
Golbahar Akhoundzadeh
Street address
Pasdaran Ave
City
Aliabad Katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
ravabet@aliabadiau.ac.ir
Grant name
Golbahar Akhoundzadeh
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aliabad Katul 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
Aliabad Katul Azad University
Full name of responsible person
Nafiseh Hekmatipoor
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pasdaran Av.
City
Aliabad Katul Azad University
Province
Golestan
Postal code
4917935965
Phone
+98 17 3422 4500
Email
n_hekmati68@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Aliabad Katul Azad University
Full name of responsible person
Aynaz Agh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rahnamaei Av.
City
Gonbad Kavoos
Province
Golestan
Postal code
49791946367
Phone
+98 17 3333 2261
Email
aynazagh123@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Aliabad Katul Azad University
Full name of responsible person
Aynaz Agh
Position
Nursse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rahnamaei St.
City
Gonbad Kavoos
Province
Golestan
Postal code
49791946367
Phone
+98 17 3333 2261
Email
aynazagh123@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
For personal reasons
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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