Pediatric Leukemia
Conditions
Keywords
emotional expression, subcutaneous tretament, pediatric nursing, video assisted intervention
Brief 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
Detailed description
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.
Interventions
OTHERVideo-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 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?"
OTHERStructured 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.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
This study is designed as a parallel-group, three-arm randomized controlled trial. Participants will be assigned to groups in a 1:1:1 ratio by computer. The randomization sequence will be generated by an independent statistician who will not be involved in the study's sample selection, intervention, or data collection phases.
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Expression | Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored | 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
| Measure | Time frame | Description |
|---|---|---|
| duration of SC process | Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored | 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 | Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored | The duration of crying in children during subcutaneous injection will be recorded in accordance with clinical protocol. |
Outcome results
None listed