Actively Recruiting
The Effect of Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency During Intravenous Immunoglobulin Access: A Crossover Randomized Controlled Trial
Led by Dr. Hatice Dönmez · Updated on 2025-06-04
32
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
D
Dr. Hatice Dönmez
Lead Sponsor
K
Karamanoğlu Mehmetbey University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study how virtual reality and tablet video viewing affect pain, fear levels, and vital signs in children with primary immunodeficiency diseases during intravenous access for immunoglobulin treatment. The trial focuses on children aged 4 to 11 who have been diagnosed and followed for at least six months, evaluating ways to reduce distress during medical procedures. Participants are randomly assigned to one of two groups: one watches a roller coaster video using virtual reality headsets, and the other watches the same video on a tablet. Both interventions begin two minutes before the venipuncture procedure and last about four minutes. Routine care and communication are maintained during the procedure, and measurements are taken during and after the intravenous access. Children's fear, pain, and emotional response scales are assessed five minutes after the procedure, along with vital signs. The study includes a screening period and monitoring during the procedure to evaluate the effectiveness of each video intervention. The trial is scheduled to run until October 2025, with all participants closely observed throughout their involvement.
CONDITIONS
Brief Title
Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single session per intervention
Participants receive either virtual reality video watching or tablet video watching during routine venipuncture procedures to assess pain and fear levels.
1 to 2 visits depending on intervention assignment
Trial Site Locations
Total: 1 location
1
Karamanoglu Mehmetbey University
Karaman, Turkey (Türkiye)
Actively Recruiting
Research Team
H
Hatice Dönmez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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