Protocol summary

Study aim
Assessing the effectiveness of storytelling on social anxiety in children with burns admitted to hospital in Ahvaz Taleghani
Design
Clinical trial with two intervention and control groups for children aged 4 to 12 years with a history of burns and hospitalization due to burns
Settings and conduct
The samples will be divided into intervention (n = 21) and control (n = 21) groups. The division of individuals into groups will be random and an attempt will be made to match the groups so that both groups have equal conditions. Then the child and his family will answer the questionnaires to participate in the study includes 2 questionnaires of children's demographic information and the questionnaire of social anxiety Watson and Friend (1969).
Participants/Inclusion and exclusion criteria
Age 4 to 12 years, having a history of burns and hospitalization due to burns, the consent of the child and her family to participate in the study and the ability to answer the questions of the questionnaires used
Intervention groups
Both groups will complete the demographic and social anxiety questionnaires. The intervention group will then receive storytelling training in 13 session.
Main outcome variables
Anxiety; quality of life; hospitalization

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210407050877N1
Registration date: 2021-05-15, 1400/02/25
Registration timing: registered_while_recruiting

Last update: 2021-05-15, 1400/02/25
Update count: 0
Registration date
2021-05-15, 1400/02/25
Registrant information
Name
masoumeh Hamid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 7992
Email address
masoumehhamid7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of storytelling on social anxiety in children with burns admitted to hospital in Ahvaz Taleghani
Public title
The effectiveness of storytelling on anxiety in children with burns admitted to hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 4 to 12 years, Having a history of burns and hospitalization due to burns, Satisfaction of the child and his family to participate in the study The ability to fill in the questionnaire
Exclusion criteria:
Participate in other counseling at the same time Dissatisfaction of the child and child's family
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size in this study was 52 people. The samples are randomly divided into two groups of 26 people. People whose two right digits of their medical file number are even will be in the control group and people whose two right digits of their medical file number are odd will be in the control group .
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 Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan , University City , Ahwaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.AJUMS.REC.1399.960

Health conditions studied

1

Description of health condition studied
social anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Before the beginning of the sessions, the Watson and Friend questionnaire, which is completed by the child's family, is used to diagnose and evaluate the social anxiety of children admitted to the hospital and to diagnose and evaluate the social anxiety of these children. Story wound burn dressing that includes 13 sessions lasting 45 minutes for these children. At the end of the fourteenth day, the Watson and Friend questionnaire is used to diagnose and re-evaluate the social anxiety of burn children.
Timepoint
Six weeks after the intervention
Method of measurement
Watson Standard Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: children between 4 and 12 years of age hospitalized for burns based on satisfaction and interest, and regularly according to training sessions such as:- Welcoming and introducing the researcher and members, dividing children into two groups of experiment and control and conducting pre-test familiarize children with the intervention program, prepare a series of story books for the experimental group and ask them to listen to the stories read by the therapist.- Teaching self-awareness and the story of the strange secret to be aware of feelings, thoughts, emotions and motivations and with the aim of helping to increase self-concept and recognize different types of emotions.- Teaching effective communication and storytelling with the title of strange guests.- Teaching interpersonal relationships (sculpture story of friendship), teaching courage or determination, courage and assertiveness (boldness) and self-confidence in the field of interpersonal communication. - Teaching empathy with the story of peacocks and greedy bears.Learning to solve problems in five steps using the big mistake story, training.- Creative thinking with the story of white teeth and bamboo stems.- Teaching critical thinking with the story of fire in the green forest, training to deal with emotions with the aim of overcoming fear, anxiety and anger.- Learning to make decisions with the story of flying over the valley of fear.- Stress management training with the aim of identifying types of stress.- Review of the issues raised and summarizing the content, implementation of post-test after 2 weeks for the intervention group
Category
Treatment - Devices

2

Description
Control group: children between 4 and 12 years of age hospitalized based on satisfaction and interest and will not receive any intervention for two weeks and will be given story books to appreciate them.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Taleghani Trauma and Burn Hospital
Full name of responsible person
Ashraf Sadat Hakim
Street address
Padadshahr - Phase 2, Hijrat Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6187954386
Phone
+98 61 3554 7992
Fax
+98 61 3554 0252
Email
hakim-3448200@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashraf Sadat Hakim
Street address
Golestan St., Jundishapur Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3733 3838
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ashraf Sadat Hakim
Position
The Coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan Street. Ahwaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3554 0525
Fax
+98 61 3554 0525
Email
hakim3448200@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashraf Sadat Hakim
Position
Coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan Street. Ahwaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3554 7992
Fax
+98 61 3554 7980
Email
hakim3448200@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashraf Sadat Hakim
Position
Coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan Street. Ahwaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61556738339
Phone
+98 61 3733 3838
Fax
+98 61 3554 0252
Email
hkim3448200@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Changes in the quality of treatment will be published as a result of story telling training activities in the treatment of children .
When the data will become available and for how long
The accessibility to data , will be one year after publication of the results .
To whom data/document is available
The data and other documents can only be used by researchers working in academic institutions .
Under which criteria data/document could be used
The results of the study can be used to complete the research of academic researchers on patients with burn anxiety.
From where data/document is obtainable
In order to access the results of the studies, it is possible to contact Ms. Ashraf-o-Sadat Hakim (listed in the Clinical Trial Registration Center of Iran) through various communication channels.
What processes are involved for a request to access data/document
Six months after the publication of the results, the applicant can send a request for the use of data and documents through the communication channels listed in the Iranian Clinical Trial Registration, and at least three months from the date of the request, an appropriate response will be provided to their request .
Comments
Loading...