search
Back to results

Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia (VR-Ege)

Primary Purpose

Symptom Cluster, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Symptom Cluster

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

  • Gülçin Özalp GerçekerRecruiting
  • Figen YardımcıRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

virtual reality distraction

control

Arm Description

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

no virtual reality distraction

Outcomes

Primary Outcome Measures

Change in symptom cluster
Symptom by Symptom Screening Tool(8-18) in SSPedi-Pediatric Patients with Cancer
Change in anxiety
anxiety by State-Trait Anxiety Inventory for Children

Secondary Outcome Measures

Full Information

First Posted
March 30, 2023
Last Updated
April 18, 2023
Sponsor
Dokuz Eylul University
Collaborators
Ege University
search

1. Study Identification

Unique Protocol Identification Number
NCT05818748
Brief Title
Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia
Acronym
VR-Ege
Official Title
Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
Collaborators
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptom Cluster, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
virtual reality distraction
Arm Type
Experimental
Arm Description
watching the application by wearing virtual glasses to the child during the 1st, 2nd and 3rd days of chemotherapy treatment
Arm Title
control
Arm Type
No Intervention
Arm Description
no virtual reality distraction
Intervention Type
Device
Intervention Name(s)
virtual reality
Intervention Description
virtual reality distraction
Primary Outcome Measure Information:
Title
Change in symptom cluster
Description
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
Title
Change in anxiety
Description
anxiety by State-Trait Anxiety Inventory for Children
Time Frame
(during the 1st, 2nd and 3rd days of chemotherapy treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülçin Özalp Gerçeker, pHD
Phone
905306411368
Email
gulcinozalp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gülçin Özalp Gerçeker, pHD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker, pHD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gülçin Ö Gerçeker
Phone
05306411368
Email
gulcinozalp@gmail.com
Facility Name
Figen Yardımcı
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Figen Yardımcı, Assoc. Prof.
Phone
+905336377703
Email
figenyardimci@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs