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NCT Number: NCT07202468

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

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.

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Key information

About this study

Children often experience pain, fear, and anxiety during invasive procedures such as peripheral intravenous catheterization. These negative experiences may reduce cooperation during treatment, cause long-term traumatic memories, and lower trust in health care. Non-pharmacological distraction methods have recently gained importance as safe, effective, and atraumatic strategies to reduce procedural pain in children. Virtual reality (VR) is a promising distraction tool that provides immersive visual and auditory stimuli, isolating the child from the hospital environment and redirecting attention away from the procedure.

This randomized controlled study will investigate the effect of two different VR applications-Aquarium VR video and Kaleidoscope VR video-on children's pain, fear, and physiological responses during peripheral intravenous catheterization. A total of 170 children, aged 7-12 years and scheduled for day surgery in the pediatric surgery unit, will be randomly assigned to one of three groups: Aquarium VR intervention, Kaleidoscope VR intervention, or routine care control. The VR interventions will start 2-3 minutes before the procedure and continue throughout catheter insertion.

Primary outcomes will be pain and fear levels, measured using validated pediatric scales including the Visual Analog Scale (VAS), Wong-Baker Faces Pain Rating Scale, and the Children's Fear Scale. Secondary outcomes will include physiological parameters (heart rate, respiratory rate, body temperature, and oxygen saturation) recorded before and after the procedure.

The study will provide evidence on whether distraction through VR can reduce pain and fear during intravenous catheterization in children and support atraumatic care principles in pediatric nursing. The findings may guide health professionals in adopting VR technology as a non-pharmacological intervention to improve the quality of care and enhance patient and family satisfaction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Virtual reality

Device
  • 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.

  • 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.

  • Routine Care (Control Group)

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

Primary outcomes

  1. Pain intensity during peripheral intravenous catheterization

    Time frame: Up to 10 minutes during and after the procedure.

    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.

  2. Pain intensity measured by Wong-Baker Faces Pain Rating Scale

    Time frame: Up to 10 minutes during and after peripheral intravenous catheterization.

    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.

  3. Fear intensity measured by Children's Fear Scale (CFS)

    Time frame: Up to 10 minutes during and after peripheral intravenous catheterization.

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

Secondary outcomes

  1. Heart rate (beats per minute)

    Time frame: Immediately before and up to 10 minutes after the procedure.

    Heart rate will be recorded before and after peripheral intravenous catheterization. Changes in heart rate will be compared between groups.

  2. Respiratory rate (breaths per minute)

    Time frame: Immediately before and up to 10 minutes after the procedure.

    Respiratory rate will be recorded before and after peripheral intravenous catheterization. Changes in respiratory rate will be compared between groups.

  3. Blood pressure (systolic and diastolic mmHg)

    Time frame: Immediately before and up to 10 minutes after the procedure.

    Systolic and diastolic blood pressure will be recorded before and after peripheral intravenous catheterization. Changes in blood pressure will be compared between groups.

  4. Oxygen saturation (percentage, %)

    Time frame: Immediately before and up to 10 minutes after the procedure.

    Peripheral oxygen saturation (SpO2) will be recorded before and after peripheral intravenous catheterization. Changes in oxygen saturation will be compared between groups.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

"The Effect of Two Different Applications Shown With Virtual Reality Glasses During Peripheral Venous Catheterization on Pain, Fear, and Physiological Parameters in Children"

Acronym: VR-PainKids

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

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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