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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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 pr
• Другое 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

Первичные конечные точки

• Change in Child State Anxiety [Срок оценки: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)]

Вторичные конечные точки (2)

• Change in Parental State Anxiety [Срок оценки: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)]
• Change in Parental Health Care Satisfaction [Срок оценки: Baseline (before intervention, prior to HSCT) Immediately after the intervention procedure (same day, after HSCT)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital — Ankara

Идентификаторы

NCT: NCT07514442 · KITAniRCT-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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