Virtual Reality and Fatigue Education

Anxiety Clinical Trial

— VRfatigue  

Official title:

The Effect of Virtual Reality and Fatigue Education on Fatigue and Anxiety Levels in Children With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05774379
• Other study ID #: 5776GOA
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2023
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It was planned to evaluate the effect of distraction intervention with virtual reality and fatigue education on the level of fatigue and anxiety in children with cancer.

Description:

H1: The fatigue scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.

H2: The anxiety scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.

Data collection After the child and his family are informed about the study, their written informed consent will be obtained. All children included in the study on the day (day 0) prior to the start of chemotherapy treatment will be given training on fatigue. In order to determine how he felt and his level of fatigue on the day of the training, it was planned to apply the Child Anxiety Scale-State (CAS-D), Child Fatigue Scale-24 Hours and Visual Fatigue Scale at 16.00 (pretest).

After randomization is achieved, a distraction intervention will be applied once a day for 10-15 minutes with virtual glasses on the 1st, 2nd and 3rd days of the chemotherapy treatment of the children in the study group. This intervention is planned to take place between 14.00-15.00 in the afternoon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 10, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• Be between 7-18 years old

• Inpatient chemotherapy treatment for more than three days

• 4 weeks over the time of diagnosis (not in the induction phase)

• Having a hemoglobin level above the criteria for transfusion of blood products (8 mg/dl for hematological malignancies, below 7 mg/dl for oncological malignancies).

• The child voluntarily agrees to participate in the study and consent is obtained from the child and parent

Exclusion Criteria:

• Being in terminal period

• undergoing a surgical operation

• Unwillingness to participate in the study

Related Conditions & MeSH terms

• Anxiety
• Fatigue

Intervention

Device:
• virtual reality and fatigue education
virtual reality distraction for 3 days and fatigue education for children

Behavioral:
• fatigue education
fatigue education for children

Locations

Country	Name	City	State
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue	Child Fatigue Scale-24 Hours: It consists of 10 items related to the perception of fatigue in children with cancer. The items in the scale contain statements that will show the child's experience of fatigue-related symptoms in the last 24 hours. The items were arranged according to likert scoring between 'never (1)' and 'a lot (5)'.	pretest, 1., 2. and 3. days of chemotheraphy
Primary	anxiety	The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety	pretest, 1., 2. and 3. days of chemotheraphy