Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia
VR-Ege
1 other identifier
interventional
40
1 country
2
Brief Summary
This study aim to evaluate the effect of virtual reality distraction on symptom management and anxiety in children aged 7-18 years with leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2023
CompletedStudy Start
First participant enrolled
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedApril 19, 2023
April 1, 2023
1 year
March 30, 2023
April 18, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Change in symptom cluster
Symptom by Symptom Screening Tool(8-18) in SSPedi-Pediatric Patients with Cancer
during the 1st, 2nd and 3rd days of chemotherapy treatment
Change in anxiety
anxiety by State-Trait Anxiety Inventory for Children
(during the 1st, 2nd and 3rd days of chemotherapy treatment)
Study Arms (2)
virtual reality distraction
EXPERIMENTALwatching the application by wearing virtual glasses to the child during the 1st, 2nd and 3rd days of chemotherapy treatment
control
NO INTERVENTIONno virtual reality distraction
Interventions
Eligibility Criteria
You may qualify if:
- Pediatric patients aged 7-18 years receiving leukemia treatment in the Pediatric Hematology Service
- weeks after diagnosis (not in the induction phase)
- No need for blood product transfusion (less than 8 mg/dl for hematological malignancies, less than 7 mg/dl for oncological malignancies)
- Consent to voluntarily participate in the study and written consent from the child and parent
You may not qualify if:
- The child has a physical and psychological deficit that will prevent him from wearing glasses to watch virtual reality
- Having a symptom of nausea and vomiting
- Being in a terminal period
- Undergoing a surgical operation
- Unwillingness to participate in the study
- Having a history of vertigo (having a history of train, motion sickness)
- The child and family do not know Turkish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dokuz Eylul Universitylead
- Ege Universitycollaborator
Study Sites (2)
Gülçin Özalp Gerçeker
Izmir, 35100, Turkey (Türkiye)
Figen Yardımcı
Izmir, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gülçin Özalp Gerçeker, pHD
Dokuz Eylul University
Central Study Contacts
Gülçin Özalp Gerçeker, pHD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- pHD, Assoc. Prof.
Study Record Dates
First Submitted
March 30, 2023
First Posted
April 19, 2023
Study Start
March 30, 2023
Primary Completion
March 30, 2024
Study Completion
March 30, 2024
Last Updated
April 19, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share