NCT06436651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
Last Updated

August 26, 2025

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

March 29, 2024

Last Update Submit

August 19, 2025

Conditions

Keywords

childcancernursingsymptom managementdigital storytelling

Outcome Measures

Primary Outcomes (4)

  • State-Trait Anxiety Inventory for Children

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

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

  • Visual Analogue Scale for Fatigue

    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.

    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.

  • The Baxter Retching Faces Scale

    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'

    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.

  • Wong-Baker FACES pain rating scale (WB-FACES)

    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.

    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 (1)

  • SSPedi: Symptom Screening Scale in Pediatric Patients

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Digital Storytelling

Control group

OTHER

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

Other: Digital Storytelling

Interventions

4 stages of digital storytelling will be implemented.

Control groupExperimental group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Universıty

Kocaeli, İzmit, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsSigns and SymptomsNarration

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsCommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 29, 2024

First Posted

May 31, 2024

Study Start

January 13, 2024

Primary Completion

July 30, 2024

Study Completion

September 27, 2024

Last Updated

August 26, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations