Symptom ClusterVR-EgeNCT05818748
Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia
A study testing virtual reality in people with Symptom Cluster and Anxiety, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
Trial summary
This study aim to evaluate the effect of virtual reality distraction on symptom management and anxiety in children aged 7-18 years with leukemia. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Symptom Cluster, Anxiety
- What is being tested?
- virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Mar 2023to 30 Mar 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients aged 7-18 years receiving leukemia treatment in the Pediatric Hematology Service
- 4 weeks after diagnosis (not in the induction phase)
- No need for blood product transfusion (less than 8 mg/dl for hematological malignancies, less than 7 mg/dl for oncological malignancies)
- Consent to voluntarily participate in the study and written consent from the child and parent
Who cannot join
- The child has a physical and psychological deficit that will prevent him from wearing glasses to watch virtual reality
- Having a symptom of nausea and vomiting
- Being in a terminal period
- Undergoing a surgical operation
- Unwillingness to participate in the study
- Having a history of vertigo (having a history of train, motion sickness)
- The child and family do not know Turkish
Trial locations and contacts
2 sites in 1 country.
Gülçin Özalp Gerçeker, pHD contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Gülçin Özalp Gerçeker
Izmir, 35100
Gülçin Ö Gerçeker, 05306411368, gulcinozalp@gmail.com
- Recruiting
Figen Yardımcı
Izmir
Figen Yardımcı, Assoc. Prof., +905336377703, figenyardimci@gmail.com
About this study
Official title: Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia: A Randomized Controlled Trial
This study aim to evaluate the effect of virtual reality distraction on symptom management and anxiety in children aged 7-18 years with leukemia.
Read the detailed description
While the virtual reality initiative was applied to the children in the study group, no harm was given to the children in the control group. The virtual reality distraction method will not be applied to the control group. After the child and his family are informed about the study, their written informed consent will be obtained.
When the patients were admitted to the clinic the day before chemotherapy treatment was started, the symptom screening scale and anxiety scale will be applied.
Control Group: The researcher stated that no additional procedure will be applied to the children in the control group and that the symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.
VR group; A distraction intervention will be applied for 10-15 minutes once a day with VR glasses. The symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.
- Conditions
- Symptom Cluster, Anxiety
- Being tested
- virtual reality
- Medical subject headings
- Syndrome, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
virtual reality distraction
| Study group | Role | What they receive |
|---|---|---|
| virtual reality distraction | Experimental | watching the application by wearing virtual glasses to the child during the 1st, 2nd and 3rd days of chemotherapy treatment Receives: Device: virtual reality |
| control | No intervention | no virtual reality distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom cluster
Symptom by Symptom Screening Tool(8-18) in SSPedi-Pediatric Patients with Cancer
Measured: during the 1st, 2nd and 3rd days of chemotherapy treatment
Change in anxiety
anxiety by State-Trait Anxiety Inventory for Children
Measured: (during the 1st, 2nd and 3rd days of chemotherapy treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start30 Mar 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom ClusterStudies 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
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, pHD, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818748
- Sponsor's protocol ID
- VR Ege
- Acronym
- VR-Ege
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05818748
- Acronym / sponsor ID
- VR-Ege / VR Ege
- Conditions
- Symptom Cluster, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 19 Apr 2023 (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 aim to evaluate the effect of virtual reality distraction on symptom management and anxiety in children aged 7-18 years with leukemia.
Detailed description
While the virtual reality initiative was applied to the children in the study group, no harm was given to the children in the control group. The virtual reality distraction method will not be applied to the control group. After the child and his family are informed about the study, their written informed consent will be obtained.
When the patients were admitted to the clinic the day before chemotherapy treatment was started, the symptom screening scale and anxiety scale will be applied.
Control Group: The researcher stated that no additional procedure will be applied to the children in the control group and that the symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.
VR group; A distraction intervention will be applied for 10-15 minutes once a day with VR glasses. The symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised
| Arm | Type | Receives |
|---|---|---|
| virtual reality distraction | Experimental | Device: virtual realitywatching the application by wearing virtual glasses to the child during the 1st, 2nd and 3rd days of chemotherapy treatment |
| control | No intervention | –no virtual reality distraction |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients aged 7-18 years receiving leukemia treatment in the Pediatric Hematology Service
- 4 weeks after diagnosis (not in the induction phase)
- No need for blood product transfusion (less than 8 mg/dl for hematological malignancies, less than 7 mg/dl for oncological malignancies)
- Consent to voluntarily participate in the study and written consent from the child and parent
Key exclusion criteria (7 listed)
- The child has a physical and psychological deficit that will prevent him from wearing glasses to watch virtual reality
- Having a symptom of nausea and vomiting
- Being in a terminal period
- Undergoing a surgical operation
- Unwillingness to participate in the study
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 realityvirtual reality distraction | Device | virtual reality distraction |
Primary outcome
Change in symptom cluster
Time frame: during the 1st, 2nd and 3rd days of chemotherapy treatment
Symptom by Symptom Screening Tool(8-18) in SSPedi-Pediatric Patients with Cancer
Change in anxiety
Time frame: (during the 1st, 2nd and 3rd days of chemotherapy treatment)
anxiety by State-Trait Anxiety Inventory for Children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- 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.
Gülçin Özalp Gerçeker, pHD contact
Gülçin Özalp Gerçeker, pHD study director
Dokuz Eylul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Symptom Cluster and Anxiety, run by Dokuz Eylul University at 2 sites 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülçin Özalp Gerçeker, pHD (905306411368, gulcinozalp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom cluster (time frame: during the 1st, 2nd and 3rd days of chemotherapy treatment). The study lists 2 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 19 Apr 2023.