Virtual Reality and Fatigue Education

NCT ID: NCT05774379

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-02-10

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.

Conditions

Fatigue; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

virtual reality and fatigue education

Intervention Type: DEVICE

virtual reality distraction for 3 days and fatigue education for children

fatigue education

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

Group Type: EXPERIMENTAL

fatigue education

Intervention Type: BEHAVIORAL

fatigue education for children

Interventions

virtual reality and fatigue education

virtual reality distraction for 3 days and fatigue education for children

Intervention Type: DEVICE

fatigue education

fatigue education for children

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülçin Özalp Gerçeker, pHD, RN

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

5776GOA

Identifier Type: -

Identifier Source: org_study_id