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Virtual Reality on Pain and Fear Levels of 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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07004803
Enrollment
31
Registered
2025-06-04
Start date
2024-09-15
Completion date
2025-06-15
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immunodeficiency Diseases (PID)

Keywords

Children, Virtual Reality, Primary Immunodeficiency, Nursing care, Administration, Intravenous

Brief summary

In this study, it is aimed to investigate the effect of virtual reality and tablet video viewing intervention on pain and fear levels and vital signs of children during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration.

Interventions

OTHERVirtual reality video watching

The children in the VR experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with virtual reality headset. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Virtual reality headset will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on virtual reality headset. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure

OTHERTablet video watching

The children in the experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with Tablet. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Tablet will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on tablet. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure.

Sponsors

Dr. Hatice Dönmez
Lead SponsorOTHER
Karamanoğlu Mehmetbey University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Children's Fear Scale5 minutes
Wong-Baker Pain Scale5 minutes
Children's Emotional Manifestation Scale5 minutes

Secondary

MeasureTime frameDescription
Vital Signs5 minutesPulse, oxygen saturation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026