VRfatigue: Virtual Reality and Fatigue Education

Sponsor
Dokuz Eylul University (Other)
Overall Status
Completed
CT.gov ID
NCT05774379
Collaborator
(none)
41
1
2
10.3
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: virtual reality and fatigue education
  • Behavioral: fatigue education
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
The Effect of Virtual Reality and Fatigue Education on Fatigue and Anxiety Levels in Children With Cancer
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Feb 1, 2023
Actual Study Completion Date :
Feb 10, 2023

Arms and Interventions

Arm Intervention/Treatment
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)

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

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)

Behavioral: fatigue education
fatigue education for children

Outcome Measures

Primary Outcome Measures

  1. fatigue [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)'.

  2. anxiety [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gülçin Özalp Gerçeker İzmir Turkey 35100

Sponsors and Collaborators

  • Dokuz Eylul University

Investigators

  • Principal Investigator: Gülçin Özalp Gerçeker, pHD, RN, Dokuz Eylul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gülçin Özalp Gerçeker, pHD, Assoc. Prof., Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT05774379
Other Study ID Numbers:
  • 5776GOA
First Posted:
Mar 17, 2023
Last Update Posted:
Mar 17, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gülçin Özalp Gerçeker, pHD, Assoc. Prof., Dokuz Eylul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2023