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CompletedNCT05774379VRfatigueUpdated Mar 17, 2023

Virtual Reality and Fatigue Education

An interventional study of virtual reality and fatigue education and fatigue education in Fatigue and Anxiety, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
7 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fatigue
  • Anxiety

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Keywords

  • virtual reality
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 41 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
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

Exclusion Criteria:

  • Being in terminal period
  • undergoing a surgical operation
  • Unwillingness to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
41 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Devicevirtual reality and fatigue education

    virtual reality distraction for 3 days and fatigue education for children

  • Behavioralfatigue education

    fatigue education for children

06

What researchers measure

Primary outcomes

  1. 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)'.

    Time frame: pretest, 1., 2. and 3. days of chemotheraphy

  2. 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

    Time frame: pretest, 1., 2. and 3. days of chemotheraphy

07

Study locations

1 site
  • Gülçin Özalp Gerçeker
    İzmir, 35100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05774379
Lead sponsor
Dokuz Eylul University
Responsible party
Gülçin Özalp Gerçeker (pHD, Assoc. Prof., Dokuz Eylul University) — Principal investigator
First posted
Mar 17, 2023
Start date
Apr 1, 2022
Primary completion
Feb 1, 2023
Completion
Feb 10, 2023
Last update
Mar 17, 2023

Study contacts

Gülçin Özalp Gerçeker, pHD, RN
principal investigator · Dokuz Eylul University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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