Pediatric Anxiety DisordersNCT06771141
Virtual Reality Before Pediatric Endoscopy
A study testing Virtual Reality Video Session in people with Pediatric Anxiety Disorders, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: Clinical Study The purpose of this clinical study is to evaluate whether the use of virtual reality (VR) before endoscopy reduces anxiety levels and positively impacts vital signs in children. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Pediatric Anxiety Disorders
- What is being tested?
- Virtual Reality Video Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2024to 15 Dec 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8 to 17 years.
- Scheduled to undergo an endoscopy procedure.
- Able to provide assent, and their parents or legal guardians provide written informed consent.
- No prior exposure to virtual reality applications.
- Willing to participate in the study.
Who cannot join
- Presence of a chronic medical condition affecting cardiovascular or respiratory systems.
- Diagnosed with a severe psychiatric disorder.
- Known visual or auditory impairments that could prevent participation in a virtual reality session.
- History of seizures or epilepsy.
- Unwillingness to participate or inability to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Virtual Reality Application Before Endoscopy on Anxiety and Vital Signs in Children
Brief Summary: Clinical Study
The purpose of this clinical study is to evaluate whether the use of virtual reality (VR) before endoscopy reduces anxiety levels and positively impacts vital signs in children. This study aims to answer the following key questions:
Read more
Does the VR application reduce pre-endoscopy anxiety in children? Does the VR application improve vital signs such as heart rate, blood pressure, and oxygen saturation in children?
Researchers will compare the effects of the VR application with standard care to assess its effectiveness.
Participants:
The experimental group will undergo a 15-minute VR session before the endoscopy.
The control group will receive standard care without VR. Anxiety levels and vital signs will be measured throughout the study.
This study aims to explore whether VR technology can serve as an effective stress management tool during pediatric medical procedure
- Conditions
- Pediatric Anxiety Disorders
- Being tested
- Virtual Reality Video Session
- Keywords
- Virtual Reality, Anxiety, Endoscopy, Pediatric, Vital Signs
- 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 Video SessionBehavioural
This intervention involves a 10-minute virtual reality (VR) video session designed to reduce pre-procedural anxiety and promote relaxation in pediatric patients. The video immerses participants in a calming virtual environment with interactive and visually engaging content tailored for children. It is administered prior to the endoscopy procedure to help manage anxiety and stabilize vital signs, such as blood pressure, heart rate, and oxygen saturation. The VR session serves as a non-pharmacological approach to anxiety management during medical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | This arm includes participants who will receive a 10-minute virtual reality (VR) session before their endoscopy procedure. The VR intervention aims to reduce anxiety and stabilize vital signs (e.g., systolic/diastolic blood pressure, heart rate, oxygen saturation) by providing an immersive and interactive experience designed to distract and relax the participants. Anxiety levels and vital signs will be measured pre- and post-intervention to evaluate its effectiveness. Receives: Behavioral: Virtual Reality Video Session |
| Standard Care Control Group | No intervention | Participants in this group will receive standard care prior to the endoscopy procedure, without the VR intervention. Anxiety levels and vital signs will be measured at similar intervals to compare with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Anxiety Levels in Pediatric Patients
The primary outcome measure is the change in anxiety levels among pediatric patients undergoing endoscopy. Anxiety levels will be assessed using the State-Trait Anxiety Inventory for Children (STAIC), a validated tool for measuring anxiety in children. Scores will be measured before and after the intervention to determine the effectiveness of the virtual reality (VR) application compared to the control group receiving standard care.
Measured: Anxiety levels will be measured immediately before the intervention and immediately after the intervention on the same day as the endoscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start29 Jul 2024
- Primary completion26 Nov 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Anxiety DisordersStudies 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
- Model description
- his study uses a randomized controlled trial (RCT) design with a parallel assignment model. Participants are divided into two groups: the intervention group, which receives a virtual reality (VR) application before undergoing endoscopy, and the control group, which receives standard care. The study is open-label, meaning both participants and researchers are aware of the group assignments. This design allows for a direct comparison of the effects of the VR application on anxiety levels and vital signs in pediatric patients.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehmet bulduk, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771141
- Sponsor's protocol ID
- 2024/07-25
- Status last verified
- Jul 2024
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared to prioritize the privacy and confidentiality of participants. Additionally, it has been specified in the ethical approval that the data will only be used for the purposes of this study and will not be shared with third parties.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality Application Before Endoscopy on Anxiety and Vital Signs in Children
- ClinicalTrials.gov ID
- NCT06771141
- Acronym / sponsor ID
- 2024/07-25
- Conditions
- Pediatric Anxiety Disorders
- Keywords
- Virtual Reality, Anxiety, Endoscopy, Pediatric, Vital Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 13 Jan 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.
Brief Summary: Clinical Study
The purpose of this clinical study is to evaluate whether the use of virtual reality (VR) before endoscopy reduces anxiety levels and positively impacts vital signs in children. This study aims to answer the following key questions:
Does the VR application reduce pre-endoscopy anxiety in children? Does the VR application improve vital signs such as heart rate, blood pressure, and oxygen saturation in children?
Researchers will compare the effects of the VR application with standard care to assess its effectiveness.
Participants:
The experimental group will undergo a 15-minute VR session before the endoscopy.
The control group will receive standard care without VR. Anxiety levels and vital signs will be measured throughout the study.
This study aims to explore whether VR technology can serve as an effective stress management tool during pediatric medical procedure
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- his study uses a randomized controlled trial (RCT) design with a parallel assignment model. Participants are divided into two groups: the intervention group, which receives a virtual reality (VR) application before undergoing endoscopy, and the control group, which receives standard care. The study is open-label, meaning both participants and researchers are aware of the group assignments. This design allows for a direct comparison of the effects of the VR application on anxiety levels and vital signs in pediatric patients.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Behavioral: Virtual Reality Video SessionThis arm includes participants who will receive a 10-minute virtual reality (VR) session before their endoscopy procedure. The VR intervention aims to reduce anxiety and stabilize vital signs (e.g., systolic/diastolic blood pressure, heart rate, oxygen saturation) by providing an immersive and interactive experience designed to distract and relax the participants. Anxiety levels and vital signs will be measured pre- and post-intervention to evaluate its effectiveness. |
| Standard Care Control Group | No intervention | –Participants in this group will receive standard care prior to the endoscopy procedure, without the VR intervention. Anxiety levels and vital signs will be measured at similar intervals to compare with the experimental group. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 8 to 17 years.
- Scheduled to undergo an endoscopy procedure.
- Able to provide assent, and their parents or legal guardians provide written informed consent.
- No prior exposure to virtual reality applications.
- Willing to participate in the study.
Key exclusion criteria (5 listed)
- Presence of a chronic medical condition affecting cardiovascular or respiratory systems.
- Diagnosed with a severe psychiatric disorder.
- Known visual or auditory impairments that could prevent participation in a virtual reality session.
- History of seizures or epilepsy.
- Unwillingness to participate or inability to comply with study procedures.
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 Video SessionThis intervention involves a 10-minute virtual reality (VR) video session designed to reduce pre-procedural anxiety and promote relaxation in pediatric patients. The video immerses participants in a calming virtual environment with interactive and visually engaging content tailored for children. It is administered prior to the endoscopy procedure to help manage anxiety and stabilize vital signs, such as blood pressure, heart rate, and oxygen saturation. The VR session serves as a non-pharmacological approach to anxiety management during medical procedures. | Behavioural | Virtual Reality Intervention Group |
Primary outcome
Reduction in Anxiety Levels in Pediatric Patients
Time frame: Anxiety levels will be measured immediately before the intervention and immediately after the intervention on the same day as the endoscopy procedure.
The primary outcome measure is the change in anxiety levels among pediatric patients undergoing endoscopy. Anxiety levels will be assessed using the State-Trait Anxiety Inventory for Children (STAIC), a validated tool for measuring anxiety in children. Scores will be measured before and after the intervention to determine the effectiveness of the virtual reality (VR) application compared to the control group receiving standard care.
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 14 Jan 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared to prioritize the privacy and confidentiality of participants. Additionally, it has been specified in the ethical approval that the data will only be used for the purposes of this study and will not be shared with third parties.
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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 Video Session in people with Pediatric Anxiety Disorders, run by Yuzuncu Yil University 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 5 inclusion and 5 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 14 Jan 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?
Reduction in Anxiety Levels in Pediatric Patients (time frame: Anxiety levels will be measured immediately before the intervention and immediately after the intervention on the same day as the endoscopy procedure.). 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 14 Jan 2025.