Hematopoetic Stem Cell TransplantationCartoon-HSCTNCT07514442
Animation-Based Education to Reduce Child and Parent Anxiety During Pediatric Stem Cell Transplantation (Cartoon-HSCT)
A study testing Animation-Based Educational Video in people with Hematopoetic Stem Cell Transplantation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effect of animation-based education on state anxiety levels of children and parents and on parental satisfaction with health care during the pediatric hematopoietic stem cell transplantation (HSCT) process. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Hematopoetic Stem Cell Transplantation
- What is being tested?
- Animation-Based Educational Video
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children:
- Aged 4 to 10 years. Scheduled for hematopoietic stem cell transplantation. No previous history of hematopoietic stem cell transplantation. Ability to communicate verbally in Turkish. No diagnosed cognitive impairment. Provided age-appropriate verbal assent if aged 7 years or older. Written informed consent provided by a legal parent or guardian.
- Parents:
- Parent or legal guardian of a child aged 4 to 10 years scheduled for hematopoietic stem cell transplantation.
- Remaining with the child as the primary caregiver/companion throughout the HSCT hospitalization.
- Ability to communicate verbally in Turkish. Willingness to participate and provision of written informed consent.
Who cannot join
- Children:
- Native language other than Turkish or significant difficulty communicating in Turkish.
- Previous hematopoietic stem cell transplantation. Development of severe clinical complications before or during transplantation requires modification of the treatment protocol.
- Transfer to another clinic prior to transplantation. Significant emotional distress during the animation intervention, as assessed by the research team.
- Parents:
- Native language other than Turkish or significant difficulty communicating in Turkish.
- Change in caregiver/companion role during the transplantation process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Animation-Based Education on Child and Parent Anxiety and Care Satisfaction During the Hematopoietic Stem Cell Transplantation Process: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the effect of animation-based education on state anxiety levels of children and parents and on parental satisfaction with health care during the pediatric hematopoietic stem cell transplantation (HSCT) process.
The main questions it aims to answer are:
Read more
Does animation-based education reduce children's state anxiety before HSCT compared to standard verbal education? Does animation-based education reduce parental state anxiety and increase parental satisfaction with the care process?
Researchers will compare children and parents who receive animation-based education with those who receive routine verbal education to see if the animation-based intervention leads to lower anxiety scores and higher satisfaction levels.
Participants will:
Watch a short age-appropriate animated video explaining the HSCT procedure in a positive and understandable way (intervention group), or receive standard verbal information (control group).
Complete pre- and post-intervention questionnaires assessing child and parent state anxiety levels and parental satisfaction with care.
The study includes children aged 4-10 years who are hospitalized for hematopoietic stem cell transplantation and their accompanying parents.
- Conditions
- Hematopoetic Stem Cell Transplantation
- Being tested
- Animation-Based Educational Video, Control Group: Standard Verbal Education
- Keywords
- Child, Parents, Hematopoietic Stem Cell Transplantation, Anxiety, Personal Satisfaction
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation-Based Educational VideoOther
Also called Animated Educational Video about Hematopoietic Stem Cell Transplantation
The intervention consists of an animation-based educational video specifically designed to prepare children and their parents for the hematopoietic stem cell transplantation (HSCT) process. The video lasts approximately 6-8 minutes and uses a simple storyline, colorful visuals, and child-friendly language to explain the HSCT procedure. The aim is to help children and parents understand what will happen during the transplant process, reduce uncertainty, and minimize anxiety associated with the procedure. The video is shown to the child and their accompanying parent on the day of hospital admission (pre-transplant period) and again on the morning of transplantation to reinforce learning and provide emotional reassurance. It differs from other educational interventions by combining visual storytelling, emotional regulation cues, and simple medical explanations presented in a friendly animated format that is specifically developed for pediatric HSCT patients.
Control Group: Standard Verbal EducationOther
Also called Routine Verbal Information (Control Group)
The control condition consists of standard verbal education routinely provided to children and their parents before the hematopoietic stem cell transplantation (HSCT) procedure. The education is delivered by the researcher using simple, age-appropriate language and covers basic information about the stem sell infusion. The verbal session lasts approximately 6-8 minutes and allows parents to ask questions and clarify details about the treatment process. The aim is to provide information about the procedure in a supportive manner while maintaining the usual clinical communication style. The verbal education is given to the child and accompanying parent on the day of hospital admission and repeated on the morning of transplantation. This approach represents the routine standard of care for pre-transplant patient education in pediatric HSCT units.
| Study group | Role | What they receive |
|---|---|---|
| Animation-Based Education Intervention (Child and Parent Group): | Experimental | Participants in the intervention group (child-parent dyads) will receive an age-appropriate animation-based educational video explaining the hematopoietic stem cell transplantation process. The video will be shown on the day of hospital admission and repeated on the morning of the transplantation. Children's and parents' state anxiety levels, and parents' satisfaction with care, will be measured at baseline, immediately after the intervention, and after the transplantation procedure. Receives: Other: Animation-Based Educational Video |
| Standard Verbal Education (Control Group) | Active comparator | Participants in the control group (child-parent dyads) will receive the routine verbal education about the hematopoietic stem cell transplantation process. Verbal information will be given on the day of hospital admission and repeated on the morning of the transplantation. Children's and parents' state anxiety levels and parents' satisfaction with health care will be assessed at baseline, after the repeated verbal education, and after the transplantation procedure. Receives: Other: Control Group: Standard Verbal Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child State Anxiety
The primary outcome is the change in children's state anxiety levels measured before and after the educational intervention. Anxiety will be assessed using Children's Anxiety Meter-State, CAM-S. The scale is a visual analog tool designed in the shape of a vertical thermometer and is graded from 0 (no anxiety at all) to 10 (very high anxiety). Measurements will be taken on the day of hospital admission (baseline) and in the morning of transplantation (after the second educational session). The outcome will be calculated as the mean difference in anxiety scores (post-pre) between the animation-based education group and the standard verbal education group.
Measured: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)
Secondary outcomes (2)
Change in Parental State Anxiety
The secondary outcome is the change in parents' state anxiety levels before and after the educational intervention. Anxiety will be measured using Spielberger State Anxiety Inventory (STAI-I). Scores range from 20 to 80, with higher scores indicating greater anxiety. Measurements will be taken on the day of hospital admission (baseline) and on the morning of transplantation (after the second educational session). It is expected that parental anxiety levels will change in parallel with changes in child anxiety levels. The mean difference between post- and pre-intervention scores will be compared across the animation-based education group and the standard verbal education group to determine the effect of the intervention on parental anxiety.
Measured: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)
Change in Parental Health Care Satisfaction
The secondary outcome is the change in parents' satisfaction with health care services before and after the educational intervention. Parental satisfaction will be assessed using the PedsQL Health Care Satisfaction Scale - Parent Form, a validated instrument that evaluates parents' satisfaction with communication, information, technical skills, emotional support, and inclusion in decision-making. Scores range from 0 to 100, with higher scores indicating greater satisfaction. The scale will be administered on the day of hospital admission (baseline) and after the hematopoietic stem cell transplantation procedure (within 24 hours post-transplant). The mean difference in satisfaction scores between the animation-based education group and the standard verbal education group will be analyzed to determine the effect of the intervention on parents' satisfaction with health care.
Measured: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoetic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment, randomized, pretest-posttest design with two arms (animation-based vs. standard verbal education); single-center study in pediatric HSCT unit.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NEBAHAT BORA GÜNEŞ, Hacettepe University
- Investigators
- Nebahat Bora Gunes, Assistant Professor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514442
- Sponsor's protocol ID
- KITAniRCT-2025
- Acronym
- Cartoon-HSCT
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animation-Based Education on Child and Parent Anxiety and Care Satisfaction During the Hematopoietic Stem Cell Transplantation Process: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07514442
- Acronym / sponsor ID
- Cartoon-HSCT / KITAniRCT-2025
- Conditions
- Hematopoetic Stem Cell Transplantation
- Keywords
- Child, Parents, Hematopoietic Stem Cell Transplantation, Anxiety, Personal Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Apr 2026 (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 goal of this clinical trial is to evaluate the effect of animation-based education on state anxiety levels of children and parents and on parental satisfaction with health care during the pediatric hematopoietic stem cell transplantation (HSCT) process.
The main questions it aims to answer are:
Does animation-based education reduce children's state anxiety before HSCT compared to standard verbal education? Does animation-based education reduce parental state anxiety and increase parental satisfaction with the care process?
Researchers will compare children and parents who receive animation-based education with those who receive routine verbal education to see if the animation-based intervention leads to lower anxiety scores and higher satisfaction levels.
Participants will:
Watch a short age-appropriate animated video explaining the HSCT procedure in a positive and understandable way (intervention group), or receive standard verbal information (control group).
Complete pre- and post-intervention questionnaires assessing child and parent state anxiety levels and parental satisfaction with care.
The study includes children aged 4-10 years who are hospitalized for hematopoietic stem cell transplantation and their accompanying parents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel assignment, randomized, pretest-posttest design with two arms (animation-based vs. standard verbal education); single-center study in pediatric HSCT unit.
| Arm | Type | Receives |
|---|---|---|
| Animation-Based Education Intervention (Child and Parent Group): | Experimental | Other: Animation-Based Educational VideoParticipants in the intervention group (child-parent dyads) will receive an age-appropriate animation-based educational video explaining the hematopoietic stem cell transplantation process. The video will be shown on the day of hospital admission and repeated on the morning of the transplantation. Children's and parents' state anxiety levels, and parents' satisfaction with care, will be measured at baseline, immediately after the intervention, and after the transplantation procedure. |
| Standard Verbal Education (Control Group) | Active comparator | Other: Control Group: Standard Verbal EducationParticipants in the control group (child-parent dyads) will receive the routine verbal education about the hematopoietic stem cell transplantation process. Verbal information will be given on the day of hospital admission and repeated on the morning of the transplantation. Children's and parents' state anxiety levels and parents' satisfaction with health care will be assessed at baseline, after the repeated verbal education, and after the transplantation procedure. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 4 to 10 years. Scheduled for hematopoietic stem cell transplantation. No previous history of hematopoietic stem cell transplantation. Ability to communicate verbally in Turkish. No diagnosed cognitive impairment. Provided age-appropriate verbal assent if aged 7 years or older. Written informed consent provided by a legal parent or guardian.
- Parent or legal guardian of a child aged 4 to 10 years scheduled for hematopoietic stem cell transplantation.
- Remaining with the child as the primary caregiver/companion throughout the HSCT hospitalization.
- Ability to communicate verbally in Turkish. Willingness to participate and provision of written informed consent.
Key exclusion criteria (7 listed)
- Native language other than Turkish or significant difficulty communicating in Turkish.
- Previous hematopoietic stem cell transplantation. Development of severe clinical complications before or during transplantation requires modification of the treatment protocol.
- Transfer to another clinic prior to transplantation. Significant emotional distress during the animation intervention, as assessed by the research team.
- Native language other than Turkish or significant difficulty communicating in Turkish.
- Change in caregiver/companion role during the transplantation 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 |
|---|---|---|
| Animation-Based Educational VideoAlso: Animated Educational Video about Hematopoietic Stem Cell TransplantationThe intervention consists of an animation-based educational video specifically designed to prepare children and their parents for the hematopoietic stem cell transplantation (HSCT) process. The video lasts approximately 6-8 minutes and uses a simple storyline, colorful visuals, and child-friendly language to explain the HSCT procedure. The aim is to help children and parents understand what will happen during the transplant process, reduce uncertainty, and minimize anxiety associated with the procedure. The video is shown to the child and their accompanying parent on the day of hospital admission (pre-transplant period) and again on the morning of transplantation to reinforce learning and provide emotional reassurance. It differs from other educational interventions by combining visual storytelling, emotional regulation cues, and simple medical explanations presented in a friendly animated format that is specifically developed for pediatric HSCT patients. | Other | Animation-Based Education Intervention (Child and Parent Group): |
| Control Group: Standard Verbal EducationAlso: Routine Verbal Information (Control Group)The control condition consists of standard verbal education routinely provided to children and their parents before the hematopoietic stem cell transplantation (HSCT) procedure. The education is delivered by the researcher using simple, age-appropriate language and covers basic information about the stem sell infusion. The verbal session lasts approximately 6-8 minutes and allows parents to ask questions and clarify details about the treatment process. The aim is to provide information about the procedure in a supportive manner while maintaining the usual clinical communication style. The verbal education is given to the child and accompanying parent on the day of hospital admission and repeated on the morning of transplantation. This approach represents the routine standard of care for pre-transplant patient education in pediatric HSCT units. | Other | Standard Verbal Education (Control Group) |
Primary outcome
Change in Child State Anxiety
Time frame: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)
The primary outcome is the change in children's state anxiety levels measured before and after the educational intervention. Anxiety will be assessed using Children's Anxiety Meter-State, CAM-S. The scale is a visual analog tool designed in the shape of a vertical thermometer and is graded from 0 (no anxiety at all) to 10 (very high anxiety). Measurements will be taken on the day of hospital admission (baseline) and in the morning of transplantation (after the second educational session). The outcome will be calculated as the mean difference in anxiety scores (post-pre) between the animation-based education group and the standard verbal education group.
2 secondary outcomes
Change in Parental State Anxiety
Time frame: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)
Change in Parental Health Care Satisfaction
Time frame: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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.
Nebahat Bora Gunes, Assistant Professor study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation-Based Educational Video in people with Hematopoetic Stem Cell Transplantation, run by Hacettepe 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simge Aytac, Master's Student (+905316660480, simgeaytac@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child State Anxiety (time frame: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)). 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 7 Apr 2026.