Pain ManagementVR-PainKidsNCT07202468
Virtual Reality for Pain, Fear, and Physiological Responses During Pediatric Venous Catheterization
A study testing Virtual Reality in people with Pain Management and Fear and Anxiety, run by Ege University.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Pain Management, Fear and Anxiety
- What is being tested?
- Virtual Reality
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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"
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.
Read the 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
- Being tested
- Virtual Reality
- Medical subject headings
- Agnosia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
- 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.
- 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.
- Routine Care (Control Group)
Children in this group received standard peripheral intravenous catheterization procedure in the pediatric surgery unit without any additional distraction intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality |
| 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. Receives: Device: Virtual Reality |
| Routine care control group | No intervention | Children received standard peripheral intravenous catheterization in the pediatric surgery unit without any additional distraction intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 10 minutes during and after peripheral intravenous catheterization.
Secondary outcomes (4)
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.
Measured: Immediately before and up to 10 minutes after the procedure.
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.
Measured: 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.
Measured: 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.
Measured: Immediately before and up to 10 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Genç, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202468
- Sponsor's protocol ID
- 1051
- Acronym
- VR-PainKids
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT07202468
- Acronym / sponsor ID
- VR-PainKids / 1051
- Conditions
- Pain Management, Fear and Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aquarium VR intervention group | Experimental | Device: Virtual RealityChildren 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. |
| Kaleidoscope VR intervention group | Experimental | Device: Virtual RealityChildren 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. |
| Routine care control group | No intervention | –Children received standard peripheral intravenous catheterization in the pediatric surgery unit without any additional distraction intervention. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality1. 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. | Device | Aquarium VR intervention group, Kaleidoscope VR intervention group |
Primary outcome
Pain intensity during peripheral intravenous catheterization
Time frame: Up to 10 minutes during and after the procedure.
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.
Pain intensity measured by Wong-Baker Faces Pain Rating Scale
Time frame: Up to 10 minutes during and after peripheral intravenous catheterization.
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.
Fear intensity measured by Children's Fear Scale (CFS)
Time frame: Up to 10 minutes during and after peripheral intravenous catheterization.
CFS consists of 5 faces scored from 0 (no fear) to 4 (highest fear). Higher scores indicate greater fear.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Pain Management and Fear and Anxiety, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during peripheral intravenous catheterization (time frame: Up to 10 minutes during and after the procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.