Virtual Reality for Pain, Fear, and Physiological Responses During Pediatric Venous Catheterization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorEge University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Sequential
Treatments tested in this trial
Virtual Reality
Device1. 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.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Aquarium VR intervention groupExperimental treatment 1 intervention
Group B: Kaleidoscope VR intervention groupExperimental treatment 1 intervention
Group C: Routine care control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 10 minutes during and after the procedure.2
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.
Time frame
Up to 10 minutes during and after peripheral intravenous catheterization.3
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.
Time frame
Up to 10 minutes during and after peripheral intravenous catheterization.Secondary outcomes
1
Heart rate (beats per minute)
Heart rate will be recorded before and after peripheral intravenous catheterization. Changes in heart rate will be compared between groups.
Time frame
Immediately before and up to 10 minutes after the procedure.2
Respiratory rate (breaths per minute)
Respiratory rate will be recorded before and after peripheral intravenous catheterization. Changes in respiratory rate will be compared between groups.
Time frame
Immediately before and up to 10 minutes after the procedure.3
Blood pressure (systolic and diastolic mmHg)
Systolic and diastolic blood pressure will be recorded before and after peripheral intravenous catheterization. Changes in blood pressure will be compared between groups.
Time frame
Immediately before and up to 10 minutes after the procedure.4
Oxygen saturation (percentage, %)
Peripheral oxygen saturation (SpO2) will be recorded before and after peripheral intravenous catheterization. Changes in oxygen saturation will be compared between groups.
Time frame
Immediately before and up to 10 minutes after the procedure.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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