Determining the effect of picture books on improving the quality of sleep in children with cancer undergoing chemotherapy
Design
A single-blind, randomized, controlled, community-based, practice-based clinical trial.
Settings and conduct
The research is conducted in the pediatric oncology department of Afzalipur Hospital, Kerman, and eligible patients are selected through convenience sampling. The intervention consists of reading cancer-related comic books for three consecutive days, provided to children 30 minutes before bedtime. Answers are collected using the PSQI questionnaire before and after the intervention.
Participants/Inclusion and exclusion criteria
Being in the age range of 3 to 12 years
Intervention groups
In this intervention, for three days, children hospitalized in the chemotherapy ward are presented with five comic books with topics related to cancer and coping strategies, so that they can choose one of the stories and read it. Every night, 30 minutes before sleep, the child reads, with the possibility of reading with the help of his parents. The PSQI sleep index is completed by the researcher before and after the intervention to evaluate the effect of this activity.
Main outcome variables
The results of the research can help bedside nurses in using picture books to improve the quality of children's sleep and can be suggested to hospital managers. It can also be used in teaching nursing students to empower children and mothers. These findings may help future research and strengthen the role of nurses in creating a suitable family environment and improving the mental and physical condition of children.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220203053920N3
Registration date:2025-01-29, 1403/11/10
Registration timing:prospective
Last update:2025-01-29, 1403/11/10
Update count:0
Registration date
2025-01-29, 1403/11/10
Registrant information
Name
Reihane Moghimian Shahrbabaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9438
Email address
moghimianreihane1@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
surveying effect of comic books on improvement sleep quality in children with cancer undergoing chemotherapy
Public title
surveying effect of comic books on improvement sleep quality in children with cancer undergoing chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Passing at least 3 days of hospitalization
Diagnosed with cancer at least 4 months ago and experienced at least two rounds of chemotherapy
Experience of sleep disturbance based on the scale
Being alert, having stable hemodynamics
Admission to the ward and the presence of the parent
Ability to speak Persian
Absence of other serious co-morbidities
No history of mental illness
Exclusion criteria:
Child's non-cooperation
having acute symptoms (pain, fever, convulsions, nausea and vomiting, and severe shortness of breath)
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples into two intervention and control groups is done by simple random method and through random numbers table and in a blind way. In this way, the researcher touches one of the numbers from left to right and records the numbers and assigns them to different groups. Even numbers will be considered for the intervention group and odd numbers will be considered for the control group, and sampling will continue until the required sample size is completed in the research.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to prevent the leakage of information in both the intervention and control groups, during the implementation of the intervention, the researcher's colleague is present in the department and will monitor that the random control group does not get to know about the book and its stories, and the mother is obliged to read the comic book after finishing. By the child, hand over the book to the researcher and do not talk about the stories with the control group.
Placebo
Not used
Assignment
Parallel
Other design features
The participants in the research are divided into intervention and control groups, and the control group does not receive any intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Jahad Blvd, Ebn Sina Avenue, Somayeh Crossroads, Kerman
City
Kerman
Province
Kerman
Postal code
7613859610
Approval date
2024-07-27, 1403/05/06
Ethics committee reference number
IR.KMU.REC.1403.056
Health conditions studied
1
Description of health condition studied
cancer chemotherapy
ICD-10 code
Z51.1
ICD-10 code description
Chemotherapy session for neoplasm
Primary outcomes
1
Description
sleep quality
Timepoint
At the beginning of the study (before the start of the intervention) and in the morning after the implementation of the intervention, at least 2 hours after the child wakes up
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention group of comic books; At night, 30 minutes before going to bed for 3 consecutive days, 5 attractive comic books containing content suitable for children's age and related to cancer, treatment and coping strategies, with different titles and stories, including Franklin's collection of stories such as Lucky The Hospital Goes by Paulette Bourgeois, Dogs Get Cancer by Sherry North, etc. are provided to the child who chooses an illustrated story according to his taste and reads it alone or with the help of his parent. to do This intervention is repeated in three consecutive days for the child hospitalized in the chemotherapy department. The PSQI index questionnaire is completed by the researcher before the intervention and in the morning after the implementation of the intervention at least 2 hours after the child wakes up within 3 days.
Category
Other
2
Description
Control group: In the control group, the PSQI index questionnaire was administered by the researcher's parent in the morning after chemotherapy for three days (following three chemotherapy sessions) at least 2 hours after waking up. Also, in order to prevent participants from encountering each other, screens and private space will be used. The control group will not participate in any of the comic book reading sessions until the end of the study, and after the end of the study, they will read their favorite comic book before going to bed to avoid the feeling of discrimination.