Animation-Based Education to Reduce Child and Parent Anxiety During Pediatric Stem Cell Transplantation (Cartoon-HSCT) (Cartoon-HSCT)

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:

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 Overview

• Status: Not yet recruiting
• Conditions: Hematopoetic Stem Cell Transplantation
• Intervention / Treatment: Other: Animation-Based Educational Video; Other: Control Group: Standard Verbal Education

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simge Aytac, Master's Student; Phone Number: +905316660480; Email: simgeaytac@hacettepe.edu.tr

Study Locations

• Turkey (Türkiye)
  • Cankaya
    • Ankara, Cankaya, Turkey (Türkiye)
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Animation-Based Education Intervention (Child and Parent Group): 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.	Other: Animation-Based Educational Video; 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.; Other Names: Animated Educational Video about Hematopoietic Stem Cell Transplantation
Active Comparator: Standard Verbal Education (Control Group); 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.	Other: Control Group: Standard Verbal Education; 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 Names: Routine Verbal Information (Control Group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Nebahat Bora Gunes, Assistant Professor, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Child; Anxiety; Parents; Hematopoietic Stem Cell Transplantation; Personal Satisfaction
• Additional Relevant MeSH Terms: Mental Disorders; Behavior; Anxiety Disorders; Personal Satisfaction; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: KITAniRCT-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No