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

Not Applicable

Recruiting

• Conditions: Symptom Cluster; Anxiety
• Interventions: Device: virtual reality

• Registration Number: NCT05818748
• Lead Sponsor: Dokuz Eylul University

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.

Study Timeline

• Study Start: 2023-03-30
• Study First Submitted: 2023-03-30
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Study First Posted: 2023-04-19
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in symptom cluster	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	(during the 1st, 2nd and 3rd days of chemotherapy treatment)	anxiety by State-Trait Anxiety Inventory for Children

Trial Locations

Locations (2)

Figen Yardımcı; 🇹🇷 İzmir, Turkey

Gülçin Özalp Gerçeker; 🇹🇷 İzmir, Turkey