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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device Virtual Reality
  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, shi

Primary outcome measures

• Pain intensity during peripheral intravenous catheterization [Time frame: Up to 10 minutes during and after the procedure.]
• Pain intensity measured by Wong-Baker Faces Pain Rating Scale [Time frame: Up to 10 minutes during and after peripheral intravenous catheterization.]
• Fear intensity measured by Children's Fear Scale (CFS) [Time frame: Up to 10 minutes during and after peripheral intravenous catheterization.]

Secondary outcome measures (4)

• Heart rate (beats per minute) [Time frame: Immediately before and up to 10 minutes after the procedure.]
• Respiratory rate (breaths per minute) [Time frame: Immediately before and up to 10 minutes after the procedure.]
• Blood pressure (systolic and diastolic mmHg) [Time frame: Immediately before and up to 10 minutes after the procedure.]
• Oxygen saturation (percentage, %) [Time frame: Immediately before and up to 10 minutes after the procedure.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07202468 · 1051

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗