Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07602621

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • video-assisted structured emotional preparation,
  • structured emotional preparation only, and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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?"

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.

Primary outcomes

  1. Emotional Expression

    Time frame: 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 outcomes

  1. duration of SC process

    Time frame: 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.

  2. Duration of crying

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of Video-Assisted Emotional Preparation on Emotional Expression in Children With Cancer Undergoing Subcutaneous Procedures

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.