Using virtual reality or tablet videos to reduce pain and fear during IVIG needle placement in children with primary immunodeficiency
The Effect of Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency Applying Intravenous Immunoglobulin During Intravenous Access: A Crossover Randomized Controlled Trial
This study will try virtual reality or tablet videos to reduce pain and fear in children aged 4–11 with primary immunodeficiency during IVIG needle placement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 4 Years to 11 Years |
| Sex | All |
| Sponsor | Karamanoğlu Mehmetbey University Academic / other |
| Locations | 1 site (Karaman) |
| Trial ID | NCT07004803 on ClinicalTrials.gov |
What this trial studies
Children with primary immunodeficiency ages 4–11 who meet inclusion criteria will receive either virtual reality or tablet video distraction during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration. Pain and fear levels will be measured using age-appropriate scales and vital signs will be recorded before, during, and after the procedure. The interventions are noninvasive distraction techniques delivered at the time of needle placement and compared to routine care or each other. Data will be analyzed to determine whether VR or tablet viewing is associated with lower reported pain, reduced fear, or more stable vital signs.
Who should consider this trial
Good fit: Ideal participants are children 4–11 years old diagnosed with primary immunodeficiency for at least six months, without other chronic diseases, who can use VR glasses and whose caregivers consent.
Not a fit: Children with organ failure, fever over 37.5°C, severe dehydration, significant cognitive impairment, or inability to use VR equipment are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could reduce procedural pain and anxiety and make IVIG visits less distressing for children with primary immunodeficiency.
How similar studies have performed: Previous pediatric research has shown that virtual reality and tablet distraction can reduce pain and anxiety during needle procedures, although data specifically in primary immunodeficiency populations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being between the ages of 4-11 * Being followed up with the diagnosis of Primary Immunodeficiency for at least 6 months * To accept participation in the study voluntarily * No additional chronic disease other than primary immunodeficiency Exclusion Criteria: * Organ failure is present * Having a mental deficiency * Having a disability to use VR Glasses * Children with fever (\|\>37.5 C0) * Children with severe dehydration
Where this trial is running
Karaman
- Karamanoglu Mehmetbey University — Karaman, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Hatice Dönmez, PhD
- Email: hdonmez@kmu.edu.tr
- Phone: +905067715841
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.