Pediatric CancerNCT07537062
The EFFECT of VİRTUAL REALİTY HEADSETS on ANXİETY, FEAR and PHYSİOLOGICAL PARAMETERS in CHİLDREN With CANCER UNDERGOİNG INTRATHECAL CHEMOTHERAPY
A study testing virtual reality glasses in people with Pediatric Cancer, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of virtual reality glasses on anxiety, fear, and physiological parameters in cancer patients aged 4-10 years undergoing intrathecal chemotherapy. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to Jun 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- outside the 4-10 age range,
- have a chronic or genetic illness,
- have an intellectual, visual, or hearing impairment,
- cannot adapt to virtual reality glasses,
- are uncooperative (both themselves and their parents),
- neither they nor their parents are willing to participate in the research and have not given their verbal or written consent will not be included in the study.
Who cannot join
- outside the 4-10 age range,
- have a chronic or genetic illness,
- have an intellectual, visual, or hearing impairment,
- cannot adapt to virtual reality glasses,
- are uncooperative (both themselves and their parents),
- neither they nor their parents are willing to participate in the research and have not given their verbal or written consent will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Kayseri, 38000
eda kalaycı
About this study
Official title: THE EFFECT of VİRTUAL REALİTY HEADSETS on ANXİETY, FEAR, and PHYSİOLOGİCAL PARAMETERS in CHİLDREN With CANCER UNDERGOİNG INTRATHECAL CHEMOTHERAPY
This study was planned to determine the effect of virtual reality glasses on anxiety, fear, and physiological parameters in cancer patients aged 4-10 years undergoing intrathecal chemotherapy. The main questions that the study aimed to answer are as follows:
- Could virtual reality glasses affect the fear experienced by children undergoing intrathecal chemotherapy?
- Could virtual reality glasses affect the anxiety experienced by children undergoing intrathecal chemotherapy?
- Does virtual reality goggles have an effect on the physiological parameters of children undergoing intrathecal chemotherapy? Researchers will compare the effects of virtual reality glasses on fear, anxiety, and physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation) in children with cancer undergoing intrathecal chemotherapy to a control group that will not receive any intervention.
Cancer patients participating in the study will be given virtual reality glasses before intrathecal chemotherapy treatment.
Read the detailed description
Cancer is a chronic disease with a long follow-up and treatment process that profoundly affects the lives of children and their families. Chemotherapy (CT) is one of the frequently used methods in cancer treatment. In children with cancer, CT is administered intraarterial, intraperitoneal, intrapleural, intravenous, intramuscular, subcutaneous, oral, and intrathecal. Intrathecal CT is a method developed to cross the blood-brain barrier after the administration of systemic chemotherapy. Intrathecal CT is frequently used in pediatric oncology clinics and can cause pain, stress, anxiety, and fear in children . Before intrathecal CT, various distraction methods can be used to reduce the stress, anxiety, and fear experienced by the child. Distraction is one of the non-pharmacological methods used to better control and reduce stress, anxiety, and fear by focusing the individual's attention elsewhere. Due to its non-invasive nature and lack of known side effects, distraction methods have become the most frequently preferred methods in recent years; Examples of distraction methods include blowing a pinwheel, watching cartoons/animations and playing games on a phone/computer, inflating balloons, reading books, counting numbers, listening to music, kaleidoscopes, medical puppets, distraction cards, and virtual reality glasses (VRG). VRG, which can alter visual, auditory, and tactile sensations by creating a perception of being in a different environment, isolates the individual from real life by showing digital images (games, animations, etc.) through a headset with a lens close to the eyes. At the same time, individuals can be immersed in the virtual world by wearing headphones to prevent the perception of sounds in the environment. In these aspects, VRG is a different method from other distraction methods in that it combines multiple sensory experiences and maximizes the sense of attention. No study has been found that uses VRG to reduce anxiety, fear, and anxiety experienced by children before intrathecal chemotherapy. Therefore, this study was planned to determine the effect of pre-operative SGG (Supplementary Endoscopic Glycemia) on anxiety, fear, and physiological parameters experienced by children aged 4-10 years before intrathecal chemotherapy.
Research Hypotheses
The application of SGG to children aged 4-10 years undergoing intrathecal chemotherapy has the following effects:
H1: It has an effect on pre-operative anxiety.
H2: It has an effect on pre-operative fear.
H3: It has an effect on pre-operative physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation).
- Conditions
- Pediatric Cancer
- Being tested
- virtual reality glasses
- Keywords
- pediatrıc cancer, virtual reality glasses, intrathecal chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesOther
In this study, a Virtual Reality headset (Meta Quest 2 VR Headset) will be used to show an animated film to a child before intrathecal chemotherapy. The device is compatible with Android operating systems. Activated by applications installed on the device, the VR headset divides the image into two equal windows, providing the necessary viewfinder range for panoramic viewing. No power or connection unit is required during use. The distance between the eye and the lens is adjustable. The VR headset consists of a headset and controllers. The headset can be adjusted to the individual after being fitted. After downloading the application to be used with the VR headset, the 360-degree image automatically appears on the screen. Watching videos with the VR headset does not require an internet connection.
| Study group | Role | What they receive |
|---|---|---|
| group using virtual reality glasses | Experimental | In this study, children and their families who meet the inclusion criteria will be informed about the use of Virtual Reality Glasses, and the researcher will obtain an "Informed Consent Form." Before intrathecal chemotherapy, the Child and Family Demographic Characteristics Form and scales (thus determining the children's predicted levels of fear and anxiety before the procedure) will be administered to the children by the researcher, and the child's physiological parameters (heart rate, blood pressure, respiratory rate, oxygen saturation value) will be recorded by the researcher. Then, the children will be fitted with Virtual Reality Glasses by the researcher and shown a selected animation film (approximately 15 minutes long). Five minutes after the child finishes watching the video, the physiological parameters will be recorded again, and the scales will be administered by the researcher. Receives: Other: virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Child Anxiety Scale-State Scale (CAS-S)
The Child Anxiety Scale-State Scale (CAS-S): This visual scale, designed for children aged 4-10, resembles a thermometer, featuring a lightbulb at the bottom and 10 horizontal lines leading upwards. When administering the scale, explain to the children: "Imagine all your anxious or tense feelings are at the top of the thermometer (point to it with your finger)," "If you are slightly anxious or nervous, the feelings may increase slightly (move your finger upwards on the scale)," "If you are very, very anxious or tense, the feelings may reach the top of the lines (move your finger to the top)," "Put a line that helps us understand how anxious or tense you feel." Before using the CAS-S, check if the child has counting and sequencing skills, specifically whether they know that 5 is greater than 2. If they do not know this, the scale cannot be administered to the child.
Measured: 10 minutes before intrathecal chemotherapy and 5 minutes after the child finishes watching the video.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start5 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Kalayci, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537062
- Sponsor's protocol ID
- 2025/355
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT of VİRTUAL REALİTY HEADSETS on ANXİETY, FEAR, and PHYSİOLOGİCAL PARAMETERS in CHİLDREN With CANCER UNDERGOİNG INTRATHECAL CHEMOTHERAPY
- ClinicalTrials.gov ID
- NCT07537062
- Acronym / sponsor ID
- 2025/355
- Conditions
- Pediatric Cancer
- Keywords
- pediatrıc cancer, virtual reality glasses, intrathecal chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 17 Apr 2026 (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 was planned to determine the effect of virtual reality glasses on anxiety, fear, and physiological parameters in cancer patients aged 4-10 years undergoing intrathecal chemotherapy. The main questions that the study aimed to answer are as follows:
- Could virtual reality glasses affect the fear experienced by children undergoing intrathecal chemotherapy?
- Could virtual reality glasses affect the anxiety experienced by children undergoing intrathecal chemotherapy?
- Does virtual reality goggles have an effect on the physiological parameters of children undergoing intrathecal chemotherapy? Researchers will compare the effects of virtual reality glasses on fear, anxiety, and physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation) in children with cancer undergoing intrathecal chemotherapy to a control group that will not receive any intervention.
Cancer patients participating in the study will be given virtual reality glasses before intrathecal chemotherapy treatment.
Detailed description
Cancer is a chronic disease with a long follow-up and treatment process that profoundly affects the lives of children and their families. Chemotherapy (CT) is one of the frequently used methods in cancer treatment. In children with cancer, CT is administered intraarterial, intraperitoneal, intrapleural, intravenous, intramuscular, subcutaneous, oral, and intrathecal. Intrathecal CT is a method developed to cross the blood-brain barrier after the administration of systemic chemotherapy. Intrathecal CT is frequently used in pediatric oncology clinics and can cause pain, stress, anxiety, and fear in children . Before intrathecal CT, various distraction methods can be used to reduce the stress, anxiety, and fear experienced by the child. Distraction is one of the non-pharmacological methods used to better control and reduce stress, anxiety, and fear by focusing the individual's attention elsewhere. Due to its non-invasive nature and lack of known side effects, distraction methods have become the most frequently preferred methods in recent years; Examples of distraction methods include blowing a pinwheel, watching cartoons/animations and playing games on a phone/computer, inflating balloons, reading books, counting numbers, listening to music, kaleidoscopes, medical puppets, distraction cards, and virtual reality glasses (VRG). VRG, which can alter visual, auditory, and tactile sensations by creating a perception of being in a different environment, isolates the individual from real life by showing digital images (games, animations, etc.) through a headset with a lens close to the eyes. At the same time, individuals can be immersed in the virtual world by wearing headphones to prevent the perception of sounds in the environment. In these aspects, VRG is a different method from other distraction methods in that it combines multiple sensory experiences and maximizes the sense of attention. No study has been found that uses VRG to reduce anxiety, fear, and anxiety experienced by children before intrathecal chemotherapy. Therefore, this study was planned to determine the effect of pre-operative SGG (Supplementary Endoscopic Glycemia) on anxiety, fear, and physiological parameters experienced by children aged 4-10 years before intrathecal chemotherapy.
Research Hypotheses
The application of SGG to children aged 4-10 years undergoing intrathecal chemotherapy has the following effects:
H1: It has an effect on pre-operative anxiety.
H2: It has an effect on pre-operative fear.
H3: It has an effect on pre-operative physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group using virtual reality glasses | Experimental | Other: virtual reality glassesIn this study, children and their families who meet the inclusion criteria will be informed about the use of Virtual Reality Glasses, and the researcher will obtain an "Informed Consent Form." Before intrathecal chemotherapy, the Child and Family Demographic Characteristics Form and scales (thus determining the children's predicted levels of fear and anxiety before the procedure) will be administered to the children by the researcher, and the child's physiological parameters (heart rate, blood pressure, respiratory rate, oxygen saturation value) will be recorded by the researcher. Then, the children will be fitted with Virtual Reality Glasses by the researcher and shown a selected animation film (approximately 15 minutes long). Five minutes after the child finishes watching the video, the physiological parameters will be recorded again, and the scales will be administered by the researcher. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- outside the 4-10 age range,
- have a chronic or genetic illness,
- have an intellectual, visual, or hearing impairment,
- cannot adapt to virtual reality glasses,
- are uncooperative (both themselves and their parents),
Key exclusion criteria (6 listed)
- outside the 4-10 age range,
- have a chronic or genetic illness,
- have an intellectual, visual, or hearing impairment,
- cannot adapt to virtual reality glasses,
- are uncooperative (both themselves and their parents),
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 glassesIn this study, a Virtual Reality headset (Meta Quest 2 VR Headset) will be used to show an animated film to a child before intrathecal chemotherapy. The device is compatible with Android operating systems. Activated by applications installed on the device, the VR headset divides the image into two equal windows, providing the necessary viewfinder range for panoramic viewing. No power or connection unit is required during use. The distance between the eye and the lens is adjustable. The VR headset consists of a headset and controllers. The headset can be adjusted to the individual after being fitted. After downloading the application to be used with the VR headset, the 360-degree image automatically appears on the screen. Watching videos with the VR headset does not require an internet connection. | Other | group using virtual reality glasses |
Primary outcome
The Child Anxiety Scale-State Scale (CAS-S)
Time frame: 10 minutes before intrathecal chemotherapy and 5 minutes after the child finishes watching the video.
The Child Anxiety Scale-State Scale (CAS-S): This visual scale, designed for children aged 4-10, resembles a thermometer, featuring a lightbulb at the bottom and 10 horizontal lines leading upwards. When administering the scale, explain to the children: "Imagine all your anxious or tense feelings are at the top of the thermometer (point to it with your finger)," "If you are slightly anxious or nervous, the feelings may increase slightly (move your finger upwards on the scale)," "If you are very, very anxious or tense, the feelings may reach the top of the lines (move your finger to the top)," "Put a line that helps us understand how anxious or tense you feel." Before using the CAS-S, check if the child has counting and sequencing skills, specifically whether they know that 5 is greater than 2. If they do not know this, the scale cannot be administered to the child.
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 23 Apr 2026.
- 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.
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 in people with Pediatric Cancer, run by TC Erciyes 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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?
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?
Contact Eda Kalaycı (+905349538932, eda_kalayci937@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Child Anxiety Scale-State Scale (CAS-S) (time frame: 10 minutes before intrathecal chemotherapy and 5 minutes after the child finishes watching the video.). 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 23 Apr 2026.