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
2 other identifiers
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2024
CompletedFirst Submitted
Initial submission to the registry
May 27, 2025
CompletedFirst Posted
Study publicly available on registry
June 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2025
CompletedJune 4, 2025
May 1, 2025
1 year
May 27, 2025
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Children's Fear Scale
5 minutes
Wong-Baker Pain Scale
5 minutes
Children's Emotional Manifestation Scale
5 minutes
Secondary Outcomes (1)
Vital Signs
5 minutes
Study Arms (2)
Virtual reality group
EXPERIMENTALTablet group
ACTIVE COMPARATORInterventions
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
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.
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Hatice Dönmezlead
- Karamanoğlu Mehmetbey Universitycollaborator
Study Sites (1)
Karamanoglu Mehmetbey University
Karaman, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
May 27, 2025
First Posted
June 4, 2025
Study Start
September 15, 2024
Primary Completion
September 15, 2025
Study Completion
October 15, 2025
Last Updated
June 4, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share