The Effect of Video-Assisted Emotional Preparation on Emotional Expression in Children With Cancer Undergoing Subcutaneous Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
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
详细描述
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:
- video-assisted structured emotional preparation,
- structured emotional preparation only, and
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
In this study, due to the nature of the intervention, children and parents will not be blinded. Researcher B, who administers the video viewing and structured emotional preparation interview, is not blinded because they are aware of the intervention's content. However, multiple-blind strategies will be implemented to minimize measurement and analysis bias. Researcher A, who administers the Children's Emotional Manifestation Scale and other data collection tools, will be unaware of group assignment. Researcher A will not be present in the area where the video viewing intervention takes place and will only be admitted to the room after the video session is completed.
The nurse performing the subcutaneous injection will also be blinded so that she does not know which group the children belong to. The statistician conducting the statistical analyses will perform the analysis after the data set is coded, and the groups will be coded as A, B, and C. The group codes will not be disclosed
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
SEDA ARDAHAN SEVGİLİ
Asst. Prof.
Ege University