Protocol summary

Study aim
Effect of reality therapy on the level of perceived stress and self-efficacy of mothers of children with Down syndrome before and after intervention in intervention and control groups
Design
With a control group, based on the community of mothers of children with Down syndrome, with parallel groups, simple random
Settings and conduct
This study is done in Jahesh rehabilitation center. Eligible mothers of children with Down syndrome are given informed consent forms. They are then randomly divided into intervention (n=20) and control (n=20) groups. Both groups will fill out a demographic questionnaire, Cohen's perceived stress scale, and Sherer's self-efficacy scale. Control group receives no intervention. The intervention group receives nine 60-minute sessions on perceived stress and self-efficacy, and the effect of reality therapy on perceived stress and self-efficacy.
Participants/Inclusion and exclusion criteria
Entry: Desire to participate in research. Failure to arrive: Having a physical and mental problem.
Intervention groups
Intervention group: The intervention group received nine 60-minute sessions on perceived stress and self-efficacy and the effect of reality-therapy on perceived stress and self-efficacy. Control group: consists of 20 people who have entered the research. These people do not receive any training.
Main outcome variables
Perceived stress and Self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180119038436N1
Registration date: 2018-08-13, 1397/05/22
Registration timing: retrospective

Last update: 2018-08-13, 1397/05/22
Update count: 0
Registration date
2018-08-13, 1397/05/22
Registrant information
Name
Shiva Gharibpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3375 1978
Email address
sh.gharibpour@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-15, 1397/04/24
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of reality therapy on perceived stress and self-efficacy of mothers of children with Down syndrome in the city of Bandarabbas, 2017
Public title
Effectiveness of reality therapy on perceived stress and self-efficacy of mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers of Down syndrome children who are willing to Participate in Research. Mothers of Down syndrome children who do not have physical and psychological problems. Mothers with at least one child with Down syndrome. Mothers of Down syndrome children who have the ability to ead and write.
Exclusion criteria:
People who have participated in similar studies.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling, Simple randomization, Individual, Random Number Tables
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
Islamic Azad University of Shahrood Branch
Street address
Shahrood Blvd.Shahrood Islamic Azad University
City
Shahrud
Province
Semnan
Postal code
43189-36199
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1397.007

Health conditions studied

1

Description of health condition studied
Down Syndrome
ICD-10 code
Q90
ICD-10 code description
Down syndrome

Primary outcomes

1

Description
Perceived Stress
Timepoint
Measuring perceived stress before the intervention begins and after 9 training sessions lasts for 2 months.
Method of measurement
Cohen's Perceived Stress Questionnaire and Colleagues

2

Description
Self-efficacy
Timepoint
Self-efficacy measure before intervention and after 9 training sessions
Method of measurement
Sherer General Self-efficacy Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Includes 20 people Who have entered the research. They have 9 sessions of 60 minutes About perceived stress and self-efficacy And the effect of the therapeutic reality on perceived stress and self-efficacy learns. Control group: consists of 20 people who have entered the research. These people do not receive any training.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Welfare of Hormozgan Province
Full name of responsible person
Gholam Hossein Ranjbar
Street address
Opposite Ghadir Store., Western Side of Imam Sajjad ., Ayatollah Ghaffari Avenue
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964595
Phone
+98 76 3331 3031
Email
Sh.gharibpour@aliabadiau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Ghulam Hussein Ranjbar
Street address
Shahid Chamran Blvd., University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
mail@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Islamic Azad University
Full name of responsible person
Shiva Gharibpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Right door. 5, Ghadir Alley. 8, Ghadir Street., Azadi Shahr Cove
City
Bandar Abbas
Province
Hormozgan
Postal code
7919768589
Phone
+98 33751978
Email
sh.gharibpour@aliabadiau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shiva Gharibpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Right door. 5, Ghadir Alley. 8, Ghadir Street., Azadi Shahr Cove
City
Bandar Abbas
Province
Hormozgan
Postal code
7919768589
Phone
+98 33751978
Email
sh.gharibpour@aliabadiau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shiva Gharibpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Right door. 5, Ghadir Alley. 8, Ghadir Street., Azadi Shahr Cove
City
Bandar Abbas
Province
Hormozgan
Postal code
7919768589
Phone
+98 33751978
Email
sh.gharibpour@aliabadiau.ac.ir

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
No more information.
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
Loading...