Clinical trial NCT05818748: Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia
Official title: Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptom Cluster
Anxiety
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2023-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in symptom cluster
timeFrame: during the 1st, 2nd and 3rd days of chemotherapy treatment
measure: Change in anxiety
timeFrame: (during the 1st, 2nd and 3rd days of chemotherapy treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
city: İzmir
country: Turkey
facility: Figen Yardımcı
Study officials:
affiliation: Dokuz Eylul University
name: Gülçin Özalp Gerçeker, pHD
role: STUDY_DIRECTOR
References: