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

NCT ID: NCT07202468

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-02-01

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.

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.

Conditions

Pain Management; Fear and Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Aquarium VR intervention group

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Kaleidoscope VR intervention group

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Routine care control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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, 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Burak Genç

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1051

Identifier Type: -

Identifier Source: org_study_id