Video-Assisted Emotional Preparation and Emotional Expression During Subcutaneous Procedures in Children With Cancer

Официальное название

The Effect of Video-Assisted Emotional Preparation on Emotional Expression in Children With Cancer Undergoing Subcutaneous Procedures

Обзор

The goal of this randomized controlled trial is to evaluate whether video-assisted emotional preparation helps reduce emotional distress in children with leukemia undergoing subcutaneous procedures. The study will also examine whether this intervention affects procedure duration and crying time during the procedure. The main questions it aims to answer are: * Does video-assisted emotional preparation improve children's emotional expression during subcutaneous procedures? * Does the intervention reduce the duration of the procedure? * Does the intervention shorten crying time during the procedure? Researchers will compare video-assisted structured emotional preparation with structured emotional preparation alone and routine care to determine the effectiveness of the intervention. Participants will be randomly assigned to one of three groups: * video-assisted structured emotional preparation, * structured emotional preparation only, * or routine care

Подробное описание

This randomized controlled study aims to evaluate the effect of a video-assisted structured emotional preparation intervention on emotional expression in children aged 3-6 years diagnosed with leukemia who undergo subcutaneous procedures. The study is grounded in atraumatic and child-centered care principles and is based on the idea that developmentally appropriate emotional preparation may help children cope more effectively with stressful medical procedures.

Hospitalization and repeated needle-related procedures are major sources of fear, anxiety, and emotional distress for children with cancer. In particular, preschool children may struggle to understand medical procedures cognitively and tend to interpret experiences through symbolic and imaginative thinking. For this reason, the intervention in this study combines short video-based storytelling with a structured emotional preparation session designed according to children's developmental characteristics. The video presents the subcutaneous procedure through child-friendly metaphors such as "superheroes" and "knights helping the body," aiming to reduce threat perception and support emotional regulation before the procedure.

The study will be conducted in the Pediatric Hematology Clinic of Ege University Children's Hospital with children receiving inpatient leukemia treatment and scheduled for subcutaneous procedures. Participants will be randomly assigned to one of three groups:

1. video-assisted structured emotional preparation, 2. structured emotional preparation only, and 3. routine care control group.

Emotional expression levels, procedure duration, and crying duration will be evaluated across repeated treatment sessions. Emotional responses will be assessed using the Children's Emotional Manifestation Scale (CEMS).

The structured emotional preparation session includes emotional awareness, cognitive reframing, behavioral coping strategies, short behavioral rehearsal, controlled transition, and positive reinforcement. The intervention is designed to be brief, feasible within routine clinical workflow, and easily applicable by pediatric nurses.

By integrating developmentally appropriate visual storytelling and emotional support into pediatric oncology care, this study seeks to contribute evidence regarding non-pharmacological nursing interventions that may reduce distress during invasive procedures and improve children's procedural experiences.

Вмешательства

• Другое Video-Assisted Structured Emotional Preparation
  In addition to the structured emotional preparation interview, a short educational video will be shown, followed by a brief discussion about the video. The screening of the educational video and the brief discussion will be conducted individually by Researcher B in the child's own room. The video will be shown to the children via a tablet controlled by Researcher B; the video file will not be shared with participants or parents. Parents will be informed both verbally and in writing that, to pres
• Другое Structured Emotional Preparation
  In this group, the only intervention will be the emotional preparation interview conducted by Researcher B. Parents in this group will be asked, "Have you watched a video similar to this study, or has such content been described to you?" This information will be recorded as an indicator of contamination.

Первичные конечные точки

• Emotional Expression [Срок оценки: Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored]

Вторичные конечные точки (2)

• duration of SC process [Срок оценки: Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored]
• Duration of crying [Срок оценки: Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored]

Критерии участия

Критерии включения

• The child must be between the ages of 3 and 6,
• The child must be receiving inpatient treatment at the Pediatric Hematology Clinic,
• The child must be scheduled to undergo a subcutaneous procedure related to a leukemia diagnosis
• The child and parent must agree to participate in the study and provide written informed consent,
• The child and parent must be able to communicate in basic Turkish,
• At least one parent (mother or father) must be present with the child during the procedure.

Критерии исключения

• Development of an acute or unstable clinical condition
• The child's discharge or continuation of treatment on an outpatient basis
• A single SC procedure performed based on the child's clinical condition
• The child has received sedation or a medication causing confusion prior to the procedure
• The child has severe vision or hearing problems that prevent video viewing or a structured emotional preparation interview
• Another interventional procedure is scheduled for the same day
• Withdrawal of informed consent by the child or parent during the process
• Difficulty adhering to the study protocol (e.g., discontinuing the procedure or refusing the procedure).
• If communication or cooperation issues prevent the completion of research data, the case will be excluded from the study.

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

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07602621 · Unknown2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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