Protocol summary

Study aim
Comparison of the effect of playing and watching cartoons through virtual reality on anxiety, fear, and pain in children with acute lymphoblastic leukemia during chemotherapy in pediatric oncology departments of medical centers affiliated with Hamadan University of Medical Sciences
Design
A clinical trial with two intervention groups and one control group, Without blinding, randomized, on 93 children. Randomization is performed using a block design.
Settings and conduct
The study is being conducted at the Oncology Center of Ekbatan Hospital affiliated with Hamadan University of Medical Sciences. Playing virtual reality games and watching cartoons with virtual reality glasses is performed from 10 minutes before the start of chemotherapy until the end of it (approximately 1 hour). In the control group, playing games and watching cartoons with virtual reality is not performed. Pain intensity, fear, and anxiety will be recorded.
Participants/Inclusion and exclusion criteria
Acute lymphoblastic leukemia, first course of chemotherapy, no gastrointestinal diseases, no speech, vision, or hearing impairments, and no intellectual disability, under treatment with vincristine. Exclusion criteria: unwillingness to continue participation in the study.
Intervention groups
Virtual Reality Gaming Group: A 3D game appropriate to the child's gender and interests is selected, starting 10 minutes before chemotherapy and continuing throughout it (approximately one hour).Virtual Reality Cartoon Viewing Group: A 3D cartoon appropriate to the child's gender and interests is selected, starting 10 minutes before chemotherapy and continuing throughout it (approximately one hour).Control Group: Receives no virtual reality intervention, and the intensity of pain, fear, and anxiety is recorded 10 minutes before, during, and immediately after chemotherapy.
Main outcome variables
The intensity of pain, fear, and anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190703044082N13
Registration date: 2025-10-10, 1404/07/18
Registration timing: registered_while_recruiting

Last update: 2025-10-10, 1404/07/18
Update count: 0
Registration date
2025-10-10, 1404/07/18
Registrant information
Name
Fateme Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 4567 8904
Email address
f-mohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of virtual reality-based games and cartoon watching on anxiety, fear, and pain in children with acute lymphoblastic leukemia during chemotherapy
Public title
Comparison of the effect of virtual reality-based games and cartoon watching on anxiety, fear, and pain in children with acute lymphoblastic leukemia during chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Acute lymphoblastic leukemia Age 6 to 12 years First course of chemotherapy No speech, vision, or hearing disorders, or mental retardation No neurological deficits affecting pain perception based on medical records In stage one (Induction Phase) or stage two (Consolidation Phase) of cancer Under treatment with L-asparaginase Willingness to participate in the study Non-dominant arm line is fixed.
Exclusion criteria:
Reluctance to continue the study process Development of poisoning from chemotherapy drugs Occurrence of emergency situations such as cardiopulmonary resuscitation or seizure, etc Not playing games or watching with virtual reality glasses for more than 10 minutes
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation into three groups (playing with virtual reality, watching cartoons with virtual reality, and control), a block randomization method with blocks of 6 will be used. This method involves creating 20 blocks of 6 units each (60 combinations), with each block including two participants for each group. The three letters A (playing with virtual reality), B (watching cartoons with virtual reality), and C (control) are written on pieces of paper and placed in an envelope. The random order of drawing the letters determines the groups, for example, A for playing with virtual reality, B for watching cartoons with virtual reality, and C for control. Then, 20 blocks of six-letter combinations such as AABBCC and ABCABC are written on paper and placed in an envelope. The blocks are selected randomly with replacement. Children are assigned to groups based on the order of the selected blocks.
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 of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6817838698
Approval date
2025-09-22, 1404/06/31
Ethics committee reference number
IR.UMSHA.REC.1404.492

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity
Timepoint
Before starting chemotherapy, during chemotherapy, and after completing chemotherapy
Method of measurement
Oucher Pain Scale

2

Description
Fear
Timepoint
Before starting chemotherapy, during chemotherapy, and after completing chemotherapy
Method of measurement
Children's Fear Scale

3

Description
Anxiety
Timepoint
Before starting chemotherapy, during chemotherapy, and after completing chemotherapy
Method of measurement
Visual-Facial-Anxiety-Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In group A (virtual reality game): First, a 3D game suitable for the child's gender and interests is selected. Then, the game is started using virtual reality glasses 10 minutes before the start of chemotherapy and continues throughout the chemotherapy session (approximately one hour). Pain intensity, fear, and anxiety will be assessed 10 minutes before chemotherapy, during chemotherapy, and immediately after chemotherapy.
Category
Treatment - Other

2

Description
Intervention group: Intervention group: In group B (watching cartoons with virtual reality): First, a 3D cartoon suitable for the child's gender and interests is selected. Then, watching the cartoon using virtual reality glasses begins 10 minutes before the start of chemotherapy and continues throughout the chemotherapy session (approximately one hour). The intensity of pain, fear, and anxiety will be assessed 10 minutes before chemotherapy, during, and immediately after chemotherapy.
Category
Treatment - Other

3

Description
Control group: In group C (control): No virtual reality-based intervention is received. However, children can use routine activities such as playing or watching movies with their parents' mobile phones, but these activities will be without virtual reality technology. The intensity of pain, fear, and anxiety will be assessed 10 minutes before chemotherapy, during, and immediately after chemotherapy.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ekbatan Hospital affiliated to Hamadan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Street address
Hamadan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Hamadan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical sciences, Khajeh Rashid Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.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
Undecided - It is not yet known if there will be 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
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