Virtual reality headsets to reduce anxiety and fear during intrathecal chemotherapy in children
THE EFFECT of VİRTUAL REALİTY HEADSETS on ANXİETY, FEAR, and PHYSİOLOGİCAL PARAMETERS in CHİLDREN With CANCER UNDERGOİNG INTRATHECAL CHEMOTHERAPY
This project will try virtual reality headsets with children aged 4–10 who are receiving intrathecal chemotherapy to see if they reduce anxiety, fear, and changes in vital signs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | TC Erciyes University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kayseri) |
| Trial ID | NCT07537062 on ClinicalTrials.gov |
What this trial studies
Children with cancer aged 4–10 who are scheduled for intrathecal chemotherapy will receive virtual reality (VR) glasses immediately before the procedure while a control group receives no distraction intervention. Researchers will measure self- or observer-rated fear and anxiety and record physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation) before and during the procedure. The study uses VR as a non-pharmacological distraction tool to alter sensory input and focus attention away from the procedure. Outcomes in the VR group will be compared to the control group to determine short-term effects on emotional and physiological stress.
Who should consider this trial
Good fit: Ideal candidates are children aged 4–10 with cancer who are scheduled for intrathecal chemotherapy, can tolerate and adapt to VR goggles, and whose parents provide consent.
Not a fit: Children outside the 4–10 age range, those with intellectual, visual, or hearing impairments, those who cannot adapt to VR or are uncooperative, or those whose parents do not consent are unlikely to benefit from or be eligible for this intervention.
Why it matters
Potential benefit: If successful, this could offer a simple, non-drug way to reduce fear, anxiety, and physiologic stress during intrathecal chemotherapy for young children.
How similar studies have performed: Prior small studies of VR for pediatric procedures have shown reductions in procedural anxiety and pain, but evidence specifically for intrathecal chemotherapy is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. outside the 4-10 age range, 2. have a chronic or genetic illness, 3. have an intellectual, visual, or hearing impairment, 4. cannot adapt to virtual reality glasses, 5. are uncooperative (both themselves and their parents), 6. neither they nor their parents are willing to participate in the research and have not given their verbal or written consent will not be included in the study. Exclusion Criteria: 1. outside the 4-10 age range, 2. have a chronic or genetic illness, 3. have an intellectual, visual, or hearing impairment, 4. cannot adapt to virtual reality glasses, 5. are uncooperative (both themselves and their parents), 6. neither they nor their parents are willing to participate in the research and have not given their verbal or written consent will not be included in the study.
Where this trial is running
Kayseri
- Erciyes University — Kayseri, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Eda Kalaycı
- Email: eda_kalayci937@hotmail.com
- Phone: +905349538932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.