Determining The Effect of Parent-child Storytelling based on Quranic story on Ethical Intelligence and Spiritual lives of Children with Cystic Fibrosis
Design
A clinical trial has a control group, with parallel groups, randomized of 64 Cystic fibrosis patient. Randomization is going to compute with block by sealedenvelope.com.
Settings and conduct
Available samples will be chosen from Children's Medical Center and devide in two groups by random 4 and 6 blocks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children with Cystic fibrosis 6-9 years old, parent should have the ability of reading and access to online messengers.
Exclusion criteria: child with Endstage CF, parent with no ability of storytelling 8 weeks in a row
Intervention groups
Intervention group: The group which parent tells Quranic story.
Control group: The group which parent tells non-quranic story chosen by themselves.
Main outcome variables
Ethical intelligence, Spiritual life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220630055328N1
Registration date:2022-08-21, 1401/05/30
Registration timing:registered_while_recruiting
Last update:2022-08-21, 1401/05/30
Update count:0
Registration date
2022-08-21, 1401/05/30
Registrant information
Name
Romina Naimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4429 6978
Email address
rnaimi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-11, 1401/04/20
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Parent-child Storytelling based on Quranic story on Ethical Intelligence and Spiritual lives of Children with Cystic Fibrosis
Public title
Effect of quranic storytelling on Ethical Intelligence and Spritual lives of children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
6-9 child with Cystic fibrosis
Parent should be able to read stories
Parent should have accessibility to phone or online messenger applications
Exclusion criteria:
Child with endstage CF
Parent with no ability of storytelling 8 weeks in a row
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In order to have same number of participants in both groups, We use Sealedenvelope.com for randomization with block. We define 64 participants, two groups and block size 4 and 6 . It is going to give us a list that shows which group participants belong.
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 Nursing and Midwifery and Rehabilitation school- Medical University of Tehran
Street address
Keshavarz Ave.
City
Amol
Province
Mazandaran
Postal code
1417653761
Approval date
2022-06-18, 1401/03/28
Ethics committee reference number
IR.TUMS.FNM.REC.1401.034
Health conditions studied
1
Description of health condition studied
Cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
2
Description of health condition studied
Ethical intelligence
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Spiritual life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ethical intelligence
Timepoint
Before, one week and one month after intervention
Method of measurement
Children's Ethical Intelligence questionnaire
2
Description
Spiritual life
Timepoint
Before, one week and one month after intervention
Method of measurement
Children's spiritual Lives questionnaire
Secondary outcomes
1
Description
No secondary variable
Timepoint
No secondary variable
Method of measurement
No secondary variable
Intervention groups
1
Description
Intervention group: parent tells 8 Quranic stories chosen by research team during 8 weeks.
Category
Behavior
2
Description
Control group: parent tells 8 Non-Quranic stories chosen by themselves during 8 weeks
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Dr. Shervin Badv
Street address
Keshavarz Ave.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
cmcpr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. akbar fotuhi
Street address
Keshavarz st.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Romina Naimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Noor st.
City
Amol
Province
Mazandaran
Postal code
4617736556
Phone
+98 11 4429 6978
Email
rominanaiemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akram Sadat Hoseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4124
Email
ashoseini@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Romina Naimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Noor st.
City
Amol
Province
Mazandaran
Postal code
4617736556
Phone
+98 11 4429 6978
Email
rominanaiemi@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
No more information is needed.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Parts of data related to consequence will be shared.
When the data will become available and for how long
Data will be available after publish.
To whom data/document is available
Data will be available for faculty and researchers.
Under which criteria data/document could be used
Available for similar research
From where data/document is obtainable
mail corresponding author: rnaimi@razi.tums.ac.ir
What processes are involved for a request to access data/document
E-mail should contain propose and aim of research then author decides whether to share information or not