Virtual Reality and Fatigue Education

NCT05774379 | Completed

• 1 other identifier: 5776GOA
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Anxiety

Keywords

virtual reality

Outcome Measures

Primary Outcomes (2)

• 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)'.

  pretest, 1., 2. and 3. days of chemotheraphy

• 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

  pretest, 1., 2. and 3. days of chemotheraphy

Study Arms (2)

virtual reality and fatigue education

EXPERIMENTAL

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

fatigue education

EXPERIMENTAL

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

virtual reality and fatigue education DEVICE

virtual reality distraction for 3 days and fatigue education for children

virtual reality and fatigue education

fatigue education BEHAVIORAL

fatigue education for children

fatigue education

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be between 7-18 years old
• Inpatient chemotherapy treatment for more than three days
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue; Anxiety Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gülçin Özalp Gerçeker, pHD, RN

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pHD, Assoc. Prof.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: April 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 10, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

TU (1)