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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Animation-Based Educational Video | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simge Aytac, Master's Student | Contact | +905316660480 | simgeaytac@hacettepe.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Nebahat Bora Gunes, Assistant Professor | Hacettepe University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | Cankaya | Turkey (Türkiye) |
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Parallel assignment, randomized, pretest-posttest design with two arms (animation-based vs. standard verbal education); single-center study in pediatric HSCT unit.
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| Control Group: Standard Verbal Education | Other | 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. |
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| 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. | Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT) |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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