Effectiveness of stress management training with spiritual skills acquisition on glycemic control in children with type 1 diabetes and mental health of their mothers
The aim of this study was to evaluate the effectiveness of stress management training with spiritual skills acquisition on glycemic control in children with type 1 diabetes and mental health of their mothers.
Design
Randomized clinical trials with control group, community based and pragmatic with parallel groups, non blinded
Settings and conduct
In this study, 50 mothers with type 1 diabetic children younger than 12 years were enrolled into the study, using the convenience sampling method, from the Imam Ali (PBUH) Clinic in Shahrekord.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with type 1 diabetic children younger than 12 years, having children with type 1 diabetes for at least 3 months; exclusion criteria: history of stress management training.
Intervention groups
50 mothers with type 1 diabetic children under 12 years of age were randomly assigned to two groups of 25 (intervention and control) each. The intervention group received 6 sessions of stress management training with acquiring spiritual skills (at 2-week intervals) presented by a clinical psychologist. The content of the sessions included reviewing and acquiring life skills, spirituality, mental health, self-awareness, problem solving, forgiveness, recitations and their impact on spiritual well-being and homework. The control group did not receive any intervention.
Main outcome variables
Changes in blood glucose levels and hemoglobin glycosylated (HbA1c) in children; changes in the mental health level in mothers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190413043253N1
Registration date:2019-05-01, 1398/02/11
Registration timing:retrospective
Last update:2019-05-01, 1398/02/11
Update count:0
Registration date
2019-05-01, 1398/02/11
Registrant information
Name
Mohammadamin Esmaeeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3826 8390
Email address
ma.esmaeeli0983@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-09-06, 1397/06/15
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Effectiveness of stress management training with spiritual skills acquisition on glycemic control in children with type 1 diabetes and mental health of their mothers
Public title
Effect of stress management training with spiritual skills in treatment of type 1 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with type 1 diabetic children younger than 12 years
Children's having developed type 1 diabetes for at least 3 months
Exclusion criteria:
History of stress management training
Age
To 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
49
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by simple random sampling using two categories of cards stating letters A and B.
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 Shahrekord University of Medical Sciences
Street address
Research Deputy, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IR.SKUMS.REC.1396.256
Health conditions studied
1
Description of health condition studied
Type 1 diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Level of glycosylated hemoglobin (HbA1c)
Timepoint
Before the intervention, after the intervention
Method of measurement
Chromatography
2
Description
Level of blood glucose
Timepoint
Before the intervention, after the intervention
Method of measurement
Glucometer
3
Description
Mental health Level in mothers
Timepoint
Before the intervention, after the intervention
Method of measurement
Depression, Anxiety and Stress Scales (DASS); and Parenting Stress Index (PSI) questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They received 6 sessions of stress management training by acquiring spiritual skills (at two-week intervals) presented by a clinical psychologist. The content of the sessions included reviewing and acquiring life skills, spirituality, mental health, self-awareness, problem solving, forgiveness, recitations and their impact on spiritual well-being and homework.
Category
Lifestyle
2
Description
Control group: The control group did not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Clinic of Shahrekord
Full name of responsible person
Doctor Masoud Nikfarjam
Street address
Emam Ali Clinic of Shahrekord, Shariati Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 2696
Email
nikmas140@gmail.com
Web page address
https://imamaliclinic.skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Vice Chancellery for Research and Technology, Shahrekord University Of Medical Sciences, Kashani Boulevard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Web page address
https://research.skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Masoud Nikfarjam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 5653
Email
nikmas140@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Masoud Nikfarjam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 5653
Email
nikmas140@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Masoud Nikfarjam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 5653
Email
nikmas140@gmail.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