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

Anxiety Clinical Trial

— VR-Ege  

Official title:

Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818748
• Other study ID #: VR Ege
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2023
• Source: Dokuz Eylul University
• Contact: Gülçin Özalp Gerçeker, pHD
• Phone: 905306411368
• Email: gulcinozalp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Symptom Cluster
• Syndrome

Intervention

Device:
• virtual reality
virtual reality distraction

Locations

Country	Name	City	State
Turkey	Figen Yardimci	Izmir
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in symptom cluster	Symptom by Symptom Screening Tool(8-18) in SSPedi-Pediatric Patients with Cancer	during the 1st, 2nd and 3rd days of chemotherapy treatment
Primary	Change in anxiety	anxiety by State-Trait Anxiety Inventory for Children	(during the 1st, 2nd and 3rd days of chemotherapy treatment)