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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:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video-Assisted Structured Emotional Preparation Interview Group | Experimental | 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?" |
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| Structured Emotional Preparation Interview Group | Active Comparator | 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. |
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| Control Group | No Intervention | Children in this group will receive standard clinical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video-Assisted Structured Emotional Preparation | Other | 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?" |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored |
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Inclusion Criteria:
Exclusion Criteria:
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All individual participant data (IPD) collected during the trial that underlie the results reported in publications, including demographic characteristics, Children's Emotional Manifestation Scale (CEMS) scores, procedure duration, and crying duration, will be available upon reasonable request from the corresponding investigator after publication of the study results. Data will be de-identified prior to sharing to protect participant confidentiality.
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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.
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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
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| Structured Emotional Preparation | Other | 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. |
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| Duration of crying |
The duration of crying in children during subcutaneous injection will be recorded in accordance with clinical protocol. |
| Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored |