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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquarium VR intervention group | Experimental | 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. |
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| Kaleidoscope VR intervention group | Experimental | 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. |
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| Routine care control group | No Intervention | Children received standard peripheral intravenous catheterization in the pediatric surgery unit without any additional distraction intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device |
Children in this group received standard peripheral intravenous catheterization procedure in the pediatric surgery unit without any additional distraction intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 minutes during and after the procedure. |
| 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. | Up to 10 minutes during and after peripheral intravenous catheterization. |
| 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. | Up to 10 minutes during and after peripheral intravenous catheterization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately before and up to 10 minutes after the procedure. |
| Respiratory rate (breaths per minute) |
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Inclusion Criteria:
Exclusion Criteria:
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De-identified individual participant data (IPD) that underlie the results of this study (text, tables, figures) will be made available upon reasonable request to the corresponding researcher after publication. Data will be shared with researchers who provide a methodologically sound proposal, and access will be granted through a data sharing agreement.
Data will be available beginning 6 months after publication and will be accessible for up to 5 years.
Data will be shared with qualified researchers who submit a methodologically sound proposal and obtain approval from the principal investigator. Access will be granted through a data sharing agreement.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Children were randomly assigned into three parallel groups: (1) Aquarium VR intervention, (2) Kaleidoscope VR intervention, and (3) routine care control group. Outcomes were compared across groups.
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Respiratory rate will be recorded before and after peripheral intravenous catheterization. Changes in respiratory rate will be compared between groups. |
| Immediately before and up to 10 minutes after the procedure. |
| 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. | Immediately before and up to 10 minutes after the procedure. |
| 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. | Immediately before and up to 10 minutes after the procedure. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |