The effect of expressive writing on anxiety in 9 to15 year old children with cancer undergoing chemotherapy
Design
The clinical trial consisted of one intervention group, one control group, single -blind and randomized on 88 children with cancer aged 9 to 15 years. Children are assigned to groups based on a randomization sequence and first in first out that will be generated in advance, which is unpredictable and has no certain pattern. To assign samples to 2 groups, the block randomization method with the size of 2 and 4 blocks using block random number generator software will be used. All this will be done with software called Matlab.
Settings and conduct
This study will be performed in Amirkabir Hospital in Arak. The personal information questionnaire is completed through an interview. The Spence children's anxiety scale is also completed for both groups. Writing is 3 times and each time for at least 15 minutes and without limit in the number of sentences. After the intervention, the Spence scale is completed again, and the results are compared with the pre-test and control groups. Only data analyzers will not know how the samples are placed in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have a minimum literacy, Suitable general condition, Pass at least one course of chemotherapy
Exclusion criteria: Existence of acute stressful conditions during the last six months, Genetic disease in children
Intervention groups
Intervention group: Participants in the intervention group are asked to write about their deepest feelings about the disease, the treatments performed for their disease. Writing is 3 times and each time for at least 15 minutes without limitation in the number of sentences.
Control group: This group receives only routine therapeutic care. In this group there is no intervention.
Main outcome variables
Intensity of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051142N2
Registration date:2021-12-01, 1400/09/10
Registration timing:prospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Aida Arjloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
golmehrsherafati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of expressive writing on anxiety in children with cancer undergoing chemotherapy
Public title
The effect of expressive writing on anxiety in children with cancer undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of any cancer by a specialist doctor
Diagnosis of anxiety with a higher score of 35 using the Spence questionnaire
Children hospitalized and have a record in a medical center
Have a minimum literacy
Suitable general condition to the extent that she/he is able to participate in the study
Pass at least one course of chemotherapy
Exclusion criteria:
Existence of acute stressful conditions during the last six months
History of psychotropic and drug use during the last six months
Genetic disease in children
Age
From 9 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Children are assigned to one intervention groups and one control group based on the randomization sequence that will be generated in advance, which is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 2 and 4 blocks will be used, so that by using the software for generating random numbers in the block method, a randomization sequence will be generated according to the sample size required for the two groups. First, all the modes in which the 2 letters A, B can be put together in blocks of 2 and 4 are generated, then a block is randomly selected by placing it among the blocks and the layout pattern in that block will be used to allocate children. Finally this block will be placed in the main container and another block will be selected again. Blocks of 2 and 4 will all be in the same container. All this will be done with software called Matlab . With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak university of medical sciences
Street address
Arak university of medical sciences, Basij Sq., Sardasht region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.ARAKMU.REC.1400.158
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety rate
Timepoint
Anxiety of each patient is measured before the intervention and immediately after the intervention, 1 month and 3 months after the intervention.
Method of measurement
Anxiety is measured by the Spence Children's Anxiety Scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants write in a private and quiet place, regardless of the grammar, about their deepest feelings and thoughts about the illness and the treatments performed for their illness. The time and date of writing the expressive writing are written at the top of the handwriting sheet. Writing is 3 times, each time for at least 15 minutes and no limit on the number of sentences and 1 expressive writing is written per week on the day of chemotherapy. The intervention will last for 3 weeks for each patient.
Category
Other
2
Description
Control group: In this group, no intervention is performed, the control group receives only routine therapeutic care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Mahbobeh Sajadi
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3943 4364
Email
golmehrsherafati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
DR Alireza Kamali
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3943 4364
Email
golmehrsherafati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
80
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
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great Prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.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
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the part of the data related to the original outcome will be able to be shared.
When the data will become available and for how long
since the spring of 2022
To whom data/document is available
Researchers and students in this field
Under which criteria data/document could be used
To reduce anxiety in children during chemotherapy and in order to develop a comprehensive program aimed at the psychological healing of children with cancer and with interventions such as those related to the anxiety of children with cancer or studies related to the factors affecting the mood of children with cancer, researchers can use the results of this study in these areas.
From where data/document is obtainable
Vice chancellor for education and research, Arak university of medical sciences
What processes are involved for a request to access data/document
These documents will be available on the website of Arak university of medical sciences.