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NCT Number: NCT07004803

Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency

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.

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Key information

Conditions

Primary Immunodeficiency Diseases (PID) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality video watching

Other

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

Tablet video watching

Other

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.

Primary outcomes

  1. Children's Fear Scale

    Time frame: 5 minutes

  2. Wong-Baker Pain Scale

    Time frame: 5 minutes

  3. Children's Emotional Manifestation Scale

    Time frame: 5 minutes

Secondary outcomes

  1. Vital Signs

    Time frame: 5 minutes

    Pulse, oxygen saturation

Sponsors and collaborators

Lead sponsor

Dr. Hatice Dönmez

Other

Collaborators

  • Karamanoğlu Mehmetbey University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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