Child, OnlyNCT06436651
Digital Storytelling in Symptom Management Pediatric Oncology
A study testing Digital Storytelling in people with Child, Only and Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Child, Only, Cancer, Symptoms and Signs
- What is being tested?
- Digital Storytelling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2024to 27 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Digital Storytelling Method in Symptom Method in Children With Oncological Problems
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?
Read more
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.
Read the detailed description
Participants; Enterprise Group,
- Interview (Week 1); Meeting the child, conducting a qualitative interview for needs analysis and introducing the forms
- Interview (Week 2); Finding a digital story topic
- Interview (Week 3); Writing a story on the specified topic
- Interview (Week 4); Converting the story into digital form
- Interview (Week 5); Showing the created story
- 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;
- Interview (Week 1); Meeting the child, introducing and applying the forms
- 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
- Child, Only, Cancer, Symptoms and Signs, Narration
- Being tested
- Digital Storytelling
- Keywords
- child, cancer, nursing, symptom management, digital storytelling
- Medical subject headings
- Neoplasms, Signs and Symptoms, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital StorytellingOther
4 stages of digital storytelling will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Children's group where digital storytelling method was applied and stories were created Receives: Other: Digital Storytelling |
| Control group | Other | Children's group where the stories of children in the initiative group will be watched Receives: Other: Digital Storytelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory for Children
It will be used to evaluate children's state anxiety.
Measured: 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.
Measured: 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'
Measured: 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.
Measured: 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
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.
Measured: It will be used in the 1st and 6th interviews with the child (1st week-6th week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start13 Jan 2024
- Primary completion30 Jul 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Birgul Erdogan, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436651
- Sponsor's protocol ID
- E.795978
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Digital Storytelling Method in Symptom Method in Children With Oncological Problems
- ClinicalTrials.gov ID
- NCT06436651
- Acronym / sponsor ID
- E.795978
- Conditions
- Child, Only, Cancer, Symptoms and Signs, Narration
- Keywords
- child, cancer, nursing, symptom management, digital storytelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
- Interview (Week 1); Meeting the child, conducting a qualitative interview for needs analysis and introducing the forms
- Interview (Week 2); Finding a digital story topic
- Interview (Week 3); Writing a story on the specified topic
- Interview (Week 4); Converting the story into digital form
- Interview (Week 5); Showing the created story
- 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;
- Interview (Week 1); Meeting the child, introducing and applying the forms
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Digital StorytellingChildren's group where digital storytelling method was applied and stories were created |
| Control group | Other | Other: Digital StorytellingChildren's group where the stories of children in the initiative group will be watched |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Storytelling4 stages of digital storytelling will be implemented. | Other | Control group, Experimental group |
Primary outcome
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).
It will be used to evaluate children's state anxiety.
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.
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.
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.
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'
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.
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Child, Only
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
Myopia, Myopia Progression
RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
High Grade Glioma, CNS Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Storytelling in people with Child, Only and Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.