About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Video-Assisted Structured Emotional Preparation
Other interventionIn 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 preserve the integrity of the study, they must not share the video content with other parents or children or describe it to children in other groups. Additionally, during the assessments on Days 15 and 30, a brief follow-up question will be asked of the parent: "Have you shared the video with another family so far? Have you described the content to anyone else? Have you heard any information about this content from another family?"
Structured Emotional Preparation
Other interventionIn 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.
Treatment groups
Trial outcomes
Primary outcomes
Emotional Expression
Children's Emotional Manifestation Scale is used to assess the anxiety children experience during medical procedures. A total score between 5 and 25 is obtained. A higher score is associated with higher levels of anxiety.
Secondary outcomes
duration of SC process
The duration of the subcutaneous injection will be recorded in accordance with the clinical procedure. This duration will begin immediately before the nurse cleans the skin and end when a cotton ball is placed over the injection site.
Duration of crying
The duration of crying in children during subcutaneous injection will be recorded in accordance with clinical protocol.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: