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Completed
NCT07742059
My Hospital Buddy Ida: AR-CBT for Children With Cancer
Conditions: Pediatric Cancer, Cancer-Related Distress, Quality of Life, Anxiety
Sex: All
Ages: 6 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 114
Sponsor: Koç University
Location: Akdeniz Üniversitesi Hastanesi Antalya
Summary
The goal of this clinical trial is to learn if an augmented reality (AR) mobile app-based cognitive behavioral therapy (CBT) program can help children aged 6 to 12 years who are being treated for cancer cope with treatment-related distress and improve their quality of life. The main questions it aims to answer are:
* Does an AR-supported CBT app improve health-related quality of life compared with the same CBT content delivered on paper, and compared with usual care?
* Does the AR-CBT app improve resilience, emotional and behavioral functioning, anxiety, and treatment-related symptoms such as nausea and fatigue, compared with the other two groups?
Researchers will compare three groups: an AR-CBT group using a smartphone/tablet app called "My Hospital Buddy Ida," a Standard CBT group receiving the same content through a printed workbook, and a usual care control group, to see if the AR app leads to greater improvement in quality of life and related outcomes.
Participants will:
* Be randomly assigned to one of the three groups
* Complete a 12-module, 9-session CBT and Child Life program (AR-CBT and Standard CBT groups) or continue usual hospital care (control group)
* Complete questionnaires about quality of life, resilience, emotional and behavioral symptoms, anxiety, and treatment-related symptoms before and after the program (approximately 9 to 12 weeks later)
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of any childhood cancer
* Currently within the first 4 months of chemotherapy treatment
* Has completed at least 1 prior chemotherapy cycle
* Sufficient Turkish language ability to complete study measures
* Presence of a literate caregiver able to provide consent and assist with study procedures
Exclusion Criteria:
* Chronic illness other than cancer
* Diagnosed brain disease
* Epilepsy
* Severe neurodevelopmental or neurological disorder
* Clouded consciousness or delirium
* History of motion sickness
* Sensory or cognitive impairment precluding use of the AR application
Source: ClinicalTrials.gov (NCT07742059). StuddyBuddy aggregates publicly available trial information.