Video-Assisted Emotional Preparation and Emotional Expression During Subcutaneous Procedures in C… (NCT07602621) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Video-Assisted Emotional Preparation and Emotional Expression During Subcutaneous Procedures in Children With Cancer
60 participantsStarted 2026-07-01
Plain-language summary
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
Who can participate
Age range
3 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Emotional Expression
Timeframe: Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored