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

NCT ID: NCT05818748

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2024-03-30

Brief Summary

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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

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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

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Symptom Cluster Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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virtual reality distraction

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

Group Type EXPERIMENTAL

virtual reality

Intervention Type DEVICE

virtual reality distraction

control

no virtual reality distraction

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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virtual reality

virtual reality distraction

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülçin Özalp Gerçeker, pHD

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

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Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Figen Yardımcı

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gülçin Özalp Gerçeker, pHD

Role: CONTACT

905306411368

Gülçin Özalp Gerçeker, pHD

Role: CONTACT

Facility Contacts

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Gülçin Ö Gerçeker

Role: primary

05306411368

Figen Yardımcı, Assoc. Prof.

Role: primary

+905336377703

Other Identifiers

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VR Ege

Identifier Type: -

Identifier Source: org_study_id

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