## Protocol Section
### Identification Module
**NCT ID:** NCT05774379

**Acronym:** VRfatigue

**Brief Title:** Virtual Reality and Fatigue Education

**Official Title:** The Effect of Virtual Reality and Fatigue Education on Fatigue and Anxiety Levels in Children With Cancer

#### Organization Study ID Info
**ID:** 5776GOA
#### Organization
**Class:** OTHER
**Full Name:** Dokuz Eylul University
### Status Module
#### Completion Date
**Date:** 2023-02-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-17

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-04-01

**Type:** ACTUAL

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2023-03-17
**Type:** ACTUAL
**Study First Submit Date:** 2023-03-07
**Study First Submit QC Date:** 2023-03-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dokuz Eylul University

#### Responsible Party

**Investigator Affiliation:** Dokuz Eylul University

**Investigator Full Name:** Gülçin Özalp Gerçeker

**Investigator Title:** pHD, Assoc. Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Fatigue

- Anxiety

**Keywords:**

- virtual reality

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 41

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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)

**Intervention Names:**

- Device: virtual reality and fatigue education

**Label:** virtual reality and fatigue education

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: fatigue education

**Label:** fatigue education

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- virtual reality and fatigue education

**Description:** virtual reality distraction for 3 days and fatigue education for children

**Name:** virtual reality and fatigue education

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- fatigue education

**Description:** fatigue education for children

**Name:** fatigue education

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**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)'.

**Measure:** fatigue

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

**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

**Measure:** anxiety

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

### Eligibility Module

**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

**Maximum Age:** 18 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** İzmir

**Country:** Turkey

**Facility:** Gülçin Özalp Gerçeker

**Zip:** 35100

#### Overall Officials

**Official 1:**

**Affiliation:** Dokuz Eylul University

**Name:** Gülçin Özalp Gerçeker, pHD, RN

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8364

- Name: Fatigue

- Relevance: HIGH

- As Found: Fatigue

### Condition Browse Module - Meshes

- ID: D000005221

- Term: Fatigue

### Misc Info Module

- Version Holder: 2024-05-24
