Determining the effect of story therapy on anxiety in children with cancer undergoing chemotherapy
Design
A single-blind randomized clinical trial study using block randomization. Randomization was done using the software of www.sealedenvelope.com website.
Settings and conduct
This study was conducted in the hematology and oncology ward of Ali Asghar Children's Hospital in Tehran. Patients were randomly assigned to intervention and control groups. Intervention group patients, participated in story therapy classes for 8 weeks. The rate of anxiety was measured using the Revised Children's Manifest Anxiety Scale (RCMAS) before the intervention and 8 weeks after the intervention by the subjects or their parents. The outcome assessor in this study was blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Parent's consent to participate in the study
Children aged 6 to 18, Children with cancer (Types of cancer) undergoing chemotherapy
Exclusion criteria: Lack of physical and mental ability of the patient to participate in storytelling sessions, Patients with history of other congenital anomalies and a history of psychological diseases,Taking anti-anxiety drugs
Intervention groups
In the intervention group, patients participated in story therapy classes (10 sessions and each session for 1:30 hours) weekly and in the control group, patients did not participate in any story reading class or other psychological treatments to reduce anxiety.
Main outcome variables
Anxiety Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230923059493N1
Registration date:2023-12-26, 1402/10/05
Registration timing:retrospective
Last update:2023-12-26, 1402/10/05
Update count:0
Registration date
2023-12-26, 1402/10/05
Registrant information
Name
Afsaneh Ehtesham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 7152
Email address
afsanehehtesham@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-30, 1401/11/10
Expected recruitment end date
2023-05-31, 1402/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of story therapy on anxiety of children with cancer undergoing chemotherapy
Public title
The effect of story therapy on anxiety of children with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parent's consent to participate in the study
Children aged 6 to 18
Children with cancer (Types of cancer) undergoing chemotherapy
Exclusion criteria:
Lack of physical and mental ability of the patient to participate in storytelling sessions
Patients with history of other congenital anomalies and a history of psychological diseases
Taking anti-anxiety drugs
Age
From 6 years old to 19 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Block Randomization method was used using block size of four. The website https://www.sealedenvelope.com was used to generate randomized sequences. For the concealment, each patient was assigned a unique code through this website. The randomized list and unique codes were provided to a researcher who was not involved in the intervention, and he determined which group each patient would be placed in.
Blinding (investigator's opinion)
Single blinded
Blinding description
Physician blinding: In this study, the outcome assessor was blinded. The outcome score was calculated using a questionnaire. The researcher who gave the questionnaire to the subjects and calculated the outcome score did not know which of the groups each of the studied subjects was placed in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Iran University of Medical Sciences
Street address
Iran university of medical science, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.IUMS.FMD.REC.1401.532
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety rate
Timepoint
Before the intervention and 10 sessions after the intervention
Method of measurement
Revised Children's Manifest Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients participated in a weekly storytelling class, , for 10 weeks (1.30 hours per session). The story telling program included 11 stories with different educational goals, including deep breathing and respiratory relaxation, self-acceptance, teaching various emotions and problem solving, understanding feelings of worry and how to deal with it, separation anxiety from the primary caregivers, understanding different experiences in hospital, understanding chemotherapy and its side effects, self-confidence, self-efficacy, individual capabilities, Accepting people's differences (physical weaknesses), understanding anger and anger management, Social skills & friendships.
Category
Behavior
2
Description
Control group: In this group, the patients did not participate in any storytelling class or other psychological treatments to reduce anxiety.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar children's Hospital
Full name of responsible person
Neda Ashayeri
Street address
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
ashayeri.n@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, next to the Milad Tower, Hemat Hwy
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Ehtesham
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 4,Sheikhi Ave.,Emamzadeh Ave.,Shariati Ave
City
Tehran
Province
Tehran
Postal code
1916883583
Phone
+98 41 3724 6585
Email
afsanehehtesham@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Ehtesham
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No.4, Sheiki Alley., Emmamzade Ave., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916883583
Phone
+98 21 2260 7152
Fax
Email
afsanehehtesham@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Ehtesham
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 4, Sheiki Alley, Emmamzade St, Shariati St.
City
Tehran
Province
Tehran
Postal code
1916883583
Phone
+98 21 2260 7152
Fax
Email
afsanehehtesham@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
No - There is not 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