Virtual Reality for Pain, Fear, and Physiological Responses During Pediatric Venous Catheterization

NCT07202468 | Not Yet Recruiting

• 1 other identifier: 1051
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the effect of two different virtual reality (VR) applications on children's pain, fear, and physiological parameters during peripheral intravenous catheterization. Children between the ages of 7 and 12 who are scheduled for day surgery in the pediatric surgery unit will be randomly assigned to one of three groups: (1) Aquarium VR video, (2) Kaleidoscope VR video, or (3) routine care control group. VR interventions will begin 2-3 minutes before the procedure and will continue throughout catheter insertion. The primary outcomes will include pain and fear levels measured by validated pediatric scales, while secondary outcomes will focus on physiological parameters such as heart rate, respiratory rate, body temperature, and oxygen saturation. The purpose of this research is to determine whether distraction with VR technology can reduce procedural pain and fear in children, improve their cooperation during invasive procedures, and support atraumatic care practices in pediatric nursing.

Conditions

Pain Management; Fear and Anxiety

Outcome Measures

Primary Outcomes (3)

• Pain intensity during peripheral intravenous catheterization

  Pain intensity will be measured using the Visual Analog Scale (VAS), which is a 10 cm line anchored by "no pain" (0) and "worst possible pain" (10). Higher scores indicate greater pain intensity. Assessments will be made at baseline (before the procedure), during, and immediately after peripheral intravenous catheter insertion.

  Up to 10 minutes during and after the procedure.

• Pain intensity measured by Wong-Baker Faces Pain Rating Scale

  This scale ranges from 0 ("no hurt") to 5 ("hurts worst") with six faces representing increasing levels of pain. Higher scores indicate greater pain intensity.

  Up to 10 minutes during and after peripheral intravenous catheterization.

• Fear intensity measured by Children's Fear Scale (CFS)

  CFS consists of 5 faces scored from 0 (no fear) to 4 (highest fear). Higher scores indicate greater fear.

  Up to 10 minutes during and after peripheral intravenous catheterization.

Secondary Outcomes (4)

• Heart rate (beats per minute)

  Immediately before and up to 10 minutes after the procedure.

• Respiratory rate (breaths per minute)

  Immediately before and up to 10 minutes after the procedure.

• Blood pressure (systolic and diastolic mmHg)

  Immediately before and up to 10 minutes after the procedure.

• Oxygen saturation (percentage, %)

  Immediately before and up to 10 minutes after the procedure.

Study Arms (3)

Aquarium VR intervention group

EXPERIMENTAL

Children wore a virtual reality headset displaying a 3D aquarium video with underwater scenes. The headset was applied 2-3 minutes before peripheral intravenous catheterization and continued during the procedure to provide distraction.

Device: Virtual Reality

Kaleidoscope VR intervention group

EXPERIMENTAL

Children wore a virtual reality headset displaying a 3D kaleidoscope video with colorful geometric patterns. The headset was applied 2-3 minutes before peripheral intravenous catheterization and continued during the procedure to distract the child and reduce procedural pain and fear.

Device: Virtual Reality

Routine care control group

NO INTERVENTION

Children received standard peripheral intravenous catheterization in the pediatric surgery unit without any additional distraction intervention.

Interventions

Virtual Reality DEVICE

1. Aquarium VR Video (3D) Children in this group wore a virtual reality headset displaying a 3D Aquarium video. The video included underwater scenes with fish, sharks, and marine mammals. The VR headset was applied 2-3 minutes before the peripheral intravenous catheterization procedure and continued during the procedure to provide distraction. 2. Kaleidoscope VR Video (3D) Children in this group wore a virtual reality headset displaying a 3D Kaleidoscope video consisting of colorful, shifting geometric patterns. The VR headset was applied 2-3 minutes before the peripheral intravenous catheterization procedure and continued during the procedure to distract the child and reduce procedural pain and fear. 3. Routine Care (Control Group) Children in this group received standard peripheral intravenous catheterization procedure in the pediatric surgery unit without any additional distraction intervention.

Aquarium VR intervention group; Kaleidoscope VR intervention group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7-12 years
• Scheduled for day surgery in the pediatric surgery unit
• Undergoing first-time peripheral intravenous catheterization in the clinic
• Both child and parent provide informed consent/assent to participate
• Child and parent have no speech or visual impairment

You may not qualify if:

• Children younger than 7 or older than 12 years
• Not scheduled for day surgery in the pediatric surgery unit
• Child or parent declining participation
• Presence of speech or visual impairment in child or parent

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Agnosia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Children were randomly assigned into three parallel groups: (1) Aquarium VR intervention, (2) Kaleidoscope VR intervention, and (3) routine care control group. Outcomes were compared across groups.

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 1, 2025
• Study Start: November 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available beginning 6 months after publication and will be accessible for up to 5 years.
• Access Criteria: Data will be shared with qualified researchers who submit a methodologically sound proposal and obtain approval from the principal investigator. Access will be granted through a data sharing agreement.