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Video-Assisted Emotional Preparation and Emotional Expression During Subcutaneous Procedures in Children With Cancer

NCT07602621 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-26

No results posted yet for this study

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

Conditions

  • Pediatric Leukemia

Interventions

OTHER

Video-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?"

OTHER

Structured 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 & Collaborators

  • Ege University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-01
Completion
2027-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07602621 on ClinicalTrials.gov