Clinical trial · Interventional
Video-Assisted Emotional Preparation and Emotional Expression During Subcutaneous Procedures in Children With Cancer
The Effect of Video-Assisted Emotional Preparation on Emotional Expression in Children With Cancer Undergoing Subcutaneous Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Leukemia | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Structured Emotional Preparation | Other | — | UNRESOLVED |
| Video-Assisted Structured Emotional Preparation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Video-Assisted Structured Emotional Preparation Interview Group
- description
- 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 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?"
- interventionNames
- Other: Video-Assisted Structured Emotional Preparation
- type
- ACTIVE_COMPARATOR
- label
- Structured Emotional Preparation Interview Group
- description
- In this group, only the structured emotional preparation interview developed by Researcher B will be administered. 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 6 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available