Virtual Reality for Pain, Fear, and Physiological Responses During Pediatric Venous Catheterization (VR-PainKids)

Ege University

Status: Not yet enrolling

Conditions: Fear and Anxiety; Pain Management

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT07202468

1051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Aquarium VR intervention group

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Kaleidoscope VR intervention group

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Routine care control group

No Intervention group

Description:

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