## Protocol Section
### Identification Module
**NCT ID:** NCT06436651

**Brief Title:** Digital Storytelling in Symptom Management Pediatric Oncology

**Official Title:** Evaluation of the Effectiveness of Digital Storytelling Method in Symptom Method in Children With Oncological Problems

#### Organization Study ID Info
**ID:** E.795978
#### Organization
**Class:** OTHER
**Full Name:** Kocaeli University
### Status Module
#### Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-03-29
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Gazi University

#### Lead Sponsor

**Class:** OTHER

**Name:** Kocaeli University

#### Responsible Party

**Investigator Affiliation:** Kocaeli University

**Investigator Full Name:** Birgul Erdogan

**Investigator Title:** Research Assistant

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this clinical study is to evaluate the effectiveness of the digital storytelling method in symptom management in children diagnosed with oncology. It will also provide information about children's experiences with Digital Storytelling and the use of the method. The main questions it aims to answer are:

* Is there a difference between the anxiety scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the fatigue scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the nausea scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the pain scores of children who applied and did not apply the Digital Storytelling Method?

Participants:

Complete the first stage data forms. Visit the clinic every 7-15 days for the digital storytelling process, which consists of 4 stages. After the storytelling process is completed, have a process evaluation meeting with the researcher.

**Detailed Description:** Participants; Enterprise Group,

1. Interview (Week 1); Meeting the child, conducting a qualitative interview for needs analysis and introducing the forms
2. Interview (Week 2); Finding a digital story topic
3. Interview (Week 3); Writing a story on the specified topic
4. Interview (Week 4); Converting the story into digital form
5. Interview (Week 5); Showing the created story
6. Interview (Week 6); Conducting a qualitative interview regarding the digital storytelling process.

Each meeting will be held in 1-week periods. Primary outcome tools will be applied as pretest and posttest once in the 1st and 6th interviews, and twice in the other interviews.

Control Group;

1. Interview (Week 1); Meeting the child, introducing and applying the forms
2. Interview (Week 6); Conducting a qualitative interview regarding the digital storytelling process. Showing the videos prepared by the children in the initiative group. Application of primary outcome tools.

### Conditions Module

**Conditions:**

- Child, Only

- Cancer

- Symptoms and Signs

- Narration

**Keywords:**

- child

- cancer

- nursing

- symptom management

- digital storytelling

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Children's group where digital storytelling method was applied and stories were created

**Intervention Names:**

- Other: Digital Storytelling

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Children's group where the stories of children in the initiative group will be watched

**Intervention Names:**

- Other: Digital Storytelling

**Label:** Control group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group

- Experimental group

**Description:** 4 stages of digital storytelling will be implemented.

**Name:** Digital Storytelling

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** It will be used to evaluate children's state anxiety.

**Measure:** State-Trait Anxiety Inventory for Children

**Time Frame:** It will be used in the 1st and 6th interviews with the child (1st week-6th week).

**Description:** It is a single-item scale used to determine the intensity of fatigue in patients. The patient is asked to score his or her fatigue on a scale of 0-10. 0 means no fatigue, while 10 is considered a lot of fatigue.

**Measure:** Visual Analogue Scale for Fatigue

**Time Frame:** It will be applied in all interviews with the child (6 interviews), before and after the interview. It will be applied 12 times in 6 weeks.

**Description:** The scale is applied to children/adolescents in the 7-18 age group. There are a total of six items in the scale, ranging from no force to vomiting, and six facial expressions indicating each item. While the scale can be used by asking the child to choose the face that best suits him/her, the cartoon can also be shown and evaluated through observation. The average application time of the scale is 2 minutes and scores are given between 0-10. Using 0 as 'no nausea' and 10 as 'vomiting'

**Measure:** The Baxter Retching Faces Scale

**Time Frame:** It will be applied in all interviews with the child (6 interviews), before and after the interview. It will be applied 12 times in 6 weeks.

**Description:** This scale is used to diagnose pain in children aged 3-18. This scale has six faces representing increasing pain intensity from zero to five from left to right. The far left face has a smiling expression, indicating a pain-free state, while the far right face has a crying expression, corresponding to the most severe pain. Six facial expressions are scored from left to right on a scale of 0 to 10 points (0 points = very happy/no pain, 10 points = most severe pain). As the score from the scale increases, pain tolerance decreases, and as the score decreases, tolerance increases. The child is told to choose the face that best expresses his or her emotions.

**Measure:** Wong-Baker FACES pain rating scale (WB-FACES)

**Time Frame:** It will be applied in all interviews with the child (6 interviews), before and after the interview. It will be applied 12 times in 6 weeks.

#### Secondary Outcomes

**Description:** The screening tool includes 15 symptoms that evaluate the symptoms children have experienced in the last two days. Each symptom is evaluated with a 5-point Likert-type scoring system, and the score range varies between 0-60. Higher scores indicate that the number of symptoms and the discomfort they cause increase.

**Measure:** SSPedi: Symptom Screening Scale in Pediatric Patients

**Time Frame:** It will be used in the 1st and 6th interviews with the child (1st week-6th week).

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 7-18 years old,
* Having received at least 1 cure of treatment,
* Completed the induction phase and is in the consolidation phase,
* Children who and their parents agree to participate in the study.

Exclusion Criteria:

* who cannot speak Turkish,
* Having a secondary chronic disease
* Having a second disease that will affect the cognitive process,
* Children/adolescents who cannot complete the 4 stages of the digital storytelling process.
* Children/adolescents who cannot complete the 4 stages of the digital storytelling process.
* Children/adolescents who take a break of more than 3 weeks between storytelling processes.

**Maximum Age:** 18 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kocaeli

**Contacts:**

***Contact 1:***

- **Email:** b.erdogan0816@gmail.com

- **Name:** Birgül Erdoğan, Msc

- **Phone:** 05307980416

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Kocaeli Universıty

**State:** İzmit

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
