Determining the effect of the combined method of painting and storytelling on the anxiety and fatigue of children with cancer undergoing chemotherapy
Design
Semi-experimental design with two groups before-after
Settings and conduct
The study setting is Tehran. After obtaining permission from the ethics committee of Iran University of Medical Sciences, the researcher will enter the research setting between 12 am to 6 pm and select eligible child who meet the inclusion criteria for the study. Before the intervention, the procedure is explained to the child and parents, and written consent is given. Then the pre-test questionnaires are given to both control and intervention groups. In the intervention group, after the pre-test, the researcher with the clinical psychologist (research consultant) went to the play room located in the pediatrics' ward and provided the environment for the children to attend by placing enough tables and chairs in the room. And the room is disinfected. Then, in each treatment session, 3-4 children are invited to the play room according to the space of the room, and the combined five-day program begins. On the sixth day, the post-test is done by filling in the questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
• Age between 6 and 12 years
• Receiving two or more courses of chemotherapy
• At least 24 hours since the child's admission
• child's mastery of the Persian language
• hospitalization in the ward for 7 days
Eclusion criteria:
• Discharge of the child from the hospital
• Unwillingness to continue participating in the study
• A major distressing life event other than a child's illness, such as a parent's divorce in the past six months
Intervention groups
Combined program of storytelling and painting
Main outcome variables
Anxiety: fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230202057303N2
Registration date:2023-05-10, 1402/02/20
Registration timing:prospective
Last update:2023-05-10, 1402/02/20
Update count:0
Registration date
2023-05-10, 1402/02/20
Registrant information
Name
Mona Alinejad naenie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1180
Email address
mona_alinejad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined Drawig and storytelling techniques on anxiety and fatigue of children with cancer undergoing chemotherapy
Public title
The effect of combined Drawig and storytelling techniques on anxiety and fatigue of children with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age is between 6 and 12 years
Receiving two or more chemotherapy courses
At least 24 hours have passed since the child was admitted to the ward
Child's mastery of the Persian language
Admission to the ward for 7 days
Exclusion criteria:
Discharge of the child from the hospital during the intervention period
Major distressing life event other than the child's illness such as parental divorce, parental death, moving in the past six months
Unwillingness to continue participating in the study
Implementation of a specific therapeutic procedure during the intervention for the patient
Being in the final phase of the disease
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee's Iran university of medical sciences
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.IUMS.REC.1401.624
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
anxiety
ICD-10 code description
The essential feature is recurrent attacks of severe anxiety (panic), which are not restricted to any particular situation or set of circumstances and are therefore unpredictable. As with other anxiety disorders, the dominant symptoms include sudden onset