Virtual Reality and Fatigue Education

Overview

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.

Full Title of Study: “The Effect of Virtual Reality and Fatigue Education on Fatigue and Anxiety Levels in Children With Cancer”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Single (Investigator)
• Study Primary Completion Date: February 1, 2023

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

• Experimental: virtual reality and fatigue education
  • watching the application by wearing virtual glasses for 3 days and Providing training on fatigue to all children (1 session, average 45 minutes) (using role-play, exercise, games, coloring books and activity materials)
• Experimental: fatigue education
  • Providing training on fatigue to all children (1 session, average 45 minutes) (using role-play, exercise, games, coloring books and activity materials)

Clinical Trial Outcome Measures

Primary Measures

• fatigue
  • Time Frame: pretest, 1., 2. and 3. days of chemotheraphy
  • 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)’.
• anxiety
  • Time Frame: pretest, 1., 2. and 3. days of chemotheraphy
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Dokuz Eylul University
• Provider of Information About this Clinical Study
  • Principal Investigator: Gülçin Özalp Gerçeker, pHD, Assoc. Prof. – Dokuz Eylul University
• Overall Official(s)
  • Gülçin Özalp Gerçeker, pHD, RN, Principal Investigator, Dokuz Eylul University