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Virtual Reality and Fatigue Education (VRfatigue)

Primary Purpose

Fatigue, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality and fatigue education
fatigue education
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fatigue focused on measuring virtual reality

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gülçin Özalp Gerçeker

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

virtual reality and fatigue education

fatigue education

Arm Description

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)

Providing training on fatigue to all children (1 session, average 45 minutes) (using role-play, exercise, games, coloring books and activity materials)

Outcomes

Primary Outcome Measures

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)'.
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

Secondary Outcome Measures

Full Information

First Posted
March 7, 2023
Last Updated
March 7, 2023
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05774379
Brief Title
Virtual Reality and Fatigue Education
Acronym
VRfatigue
Official Title
The Effect of Virtual Reality and Fatigue Education on Fatigue and Anxiety Levels in Children With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Anxiety
Keywords
virtual reality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality and fatigue education
Arm Type
Experimental
Arm Description
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)
Arm Title
fatigue education
Arm Type
Experimental
Arm Description
Providing training on fatigue to all children (1 session, average 45 minutes) (using role-play, exercise, games, coloring books and activity materials)
Intervention Type
Device
Intervention Name(s)
virtual reality and fatigue education
Intervention Description
virtual reality distraction for 3 days and fatigue education for children
Intervention Type
Behavioral
Intervention Name(s)
fatigue education
Intervention Description
fatigue education for children
Primary Outcome Measure Information:
Title
fatigue
Description
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)'.
Time Frame
pretest, 1., 2. and 3. days of chemotheraphy
Title
anxiety
Description
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
Time Frame
pretest, 1., 2. and 3. days of chemotheraphy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker, pHD, RN
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

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Virtual Reality and Fatigue Education

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