ChildNCT06883929
The Effect of Virtual Reality Application on Anxiety and Fear Levels of Children Planned for Daily Surgery
A study testing virtual reality glasses and virtual reality goggles in people with Child and Fear, run by Cihat Ozyılmaz at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- What is being tested?
- virtual reality glasses and virtual reality goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Not having an audiovisual disease
Who cannot join
- Having an audiovisual disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bitlis Il Sağlık Müdürlüğü
Bitlis, Bitlis, 13000
About this study
Official title: The Effect of Vırtual Realıty Applıcatıon on the Anxıety and Fear Levels of Chıldren Who Are Planned for Daıly Surgery
Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).
Read the detailed description
Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).
- Being tested
- virtual reality glasses, virtual reality goggles
- Keywords
- Child, Anxiety, Fear, Distraction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
Animation video application with virtual glasses by the researcher himself was applied. The application was performed in a quiet environment in the patient's room, in a sitting area where the child was comfortable.
position and wearing virtual goggles over his eyes.
virtual reality gogglesDevice
vr 360 degree screen viewing
| Study group | Role | What they receive |
|---|---|---|
| Data Collection | Experimental | Equal numbers (n) (40:40) were included in the intervention and control groups by block randomization. Written informed consent was obtained from the parents and verbal consent was obtained from the children. Blood pressure and heart pulse was measured with the same calibrated devices throughout the study. The first and last measurements were evaluated by the researcher. In the intervention group five experts were consulted in order to involve children in the decision-making process. Three minutes and two six-minute video options. The videos show the forest, trees, flowers and 3D animated videos with animals and instrumental music were shown. Video maximum 30 minutes after being monitored. Both intervention and control group underwent the procedures to be applied in the preoperative period. The control group was not shown a video and only ward routines were applied. Receives: Device: virtual reality glasses; Device: virtual reality goggles |
| control group | No intervention | Routine maintenance was provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child fear scale
Child Fear Scale ranges from neutral (0 points=no fear) to frightened It consists of five different statements ranging up to one hundred (4 points=severe fear). Horror score the higher the level of fear, the higher the level of fear
Measured: 6 months
Secondary outcomes (1)
Yale modified preoperative anxiety scale pediatric form
In the scale consisting of four parts, points are evaluated all sections are scored within each section and the highest score in its section is divided by the grade. The scores from all sections are added up, divided by 4 again, and then divided by 100.
is multiplied. This calculation results in a score between 22.92-100. High score refers to high anxiety and worry.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Jan 2023
- Primary completion30 Jun 2023
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cihat Ozyılmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cihat Ozyılmaz, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883929
- Sponsor's protocol ID
- BİTLİS-HEM-CÖ-01
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vırtual Realıty Applıcatıon on the Anxıety and Fear Levels of Chıldren Who Are Planned for Daıly Surgery
- ClinicalTrials.gov ID
- NCT06883929
- Acronym / sponsor ID
- BİTLİS-HEM-CÖ-01
- Keywords
- Child, Anxiety, Fear, Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cihat OzyılmazUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 19 Mar 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.
Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).
Detailed description
Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data Collection | Experimental | Device: virtual reality glasses, Device: virtual reality gogglesEqual numbers (n) (40:40) were included in the intervention and control groups by block randomization. Written informed consent was obtained from the parents and verbal consent was obtained from the children. Blood pressure and heart pulse was measured with the same calibrated devices throughout the study. The first and last measurements were evaluated by the researcher. In the intervention group five experts were consulted in order to involve children in the decision-making process. Three minutes and two six-minute video options. The videos show the forest, trees, flowers and 3D animated videos with animals and instrumental music were shown. Video maximum 30 minutes after being monitored. Both intervention and control group underwent the procedures to be applied in the preoperative period. The control group was not shown a video and only ward routines were applied. |
| control group | No intervention | –Routine maintenance was provided |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Not having an audiovisual disease
Key exclusion criteria (1 listed)
- Having an audiovisual disease
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 reality glassesAnimation video application with virtual glasses by the researcher himself was applied. The application was performed in a quiet environment in the patient's room, in a sitting area where the child was comfortable. position and wearing virtual goggles over his eyes. | Device | Data Collection |
| virtual reality gogglesvr 360 degree screen viewing | Device | Data Collection |
Primary outcome
Child fear scale
Time frame: 6 months
Child Fear Scale ranges from neutral (0 points=no fear) to frightened It consists of five different statements ranging up to one hundred (4 points=severe fear). Horror score the higher the level of fear, the higher the level of fear
1 secondary outcome
Yale modified preoperative anxiety scale pediatric form
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses and virtual reality goggles in people with Child and Fear, run by Cihat Ozyılmaz at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Child fear scale (time frame: 6 months). 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 19 Mar 2025.