CClinicalTrials.gg
Status unknownNCT05818748VR-EgeUpdated Apr 19, 2023

Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia

An interventional study of virtual reality in Symptom Cluster and Anxiety, sponsored by Dokuz Eylul University. Status unknown at 2 sites in Turkey. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
7 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Symptom Cluster
  • Anxiety
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    virtual reality distraction

    watching the application by wearing virtual glasses to the child during the 1st, 2nd and 3rd days of chemotherapy treatment

    Device: virtual reality

  • No intervention
    control

    no virtual reality distraction

Interventions

  • Devicevirtual reality

    virtual reality distraction

06

What researchers measure

Primary outcomes

  1. Change in symptom cluster

    Symptom by Symptom Screening Tool(8-18) in SSPedi-Pediatric Patients with Cancer

    Time frame: during the 1st, 2nd and 3rd days of chemotherapy treatment

  2. Change in anxiety

    anxiety by State-Trait Anxiety Inventory for Children

    Time frame: (during the 1st, 2nd and 3rd days of chemotherapy treatment)

07

Study locations

2 of 2 sites recruiting
  • Gülçin Özalp Gerçeker
    İzmir, 35100, Turkey
    Recruiting
  • Figen Yardımcı
    İzmir, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05818748
Lead sponsor
Dokuz Eylul University
Collaborators
Ege University
Responsible party
Gülçin Özalp Gerçeker (pHD, Assoc. Prof., Dokuz Eylul University) — Principal investigator
First posted
Apr 19, 2023
Start date
Mar 30, 2023
Primary completion
Mar 30, 2024 (estimated)
Completion
Mar 30, 2024 (estimated)
Last update
Apr 19, 2023

Study contacts

Gülçin Özalp Gerçeker, pHD
Contact
gulcinozalp@gmail.com
905306411368
Gülçin Özalp Gerçeker, pHD
Contact
Gülçin Özalp Gerçeker, pHD
study director · Dokuz Eylul University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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