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

May 21, 2026 updated by: SEDA ARDAHAN SEVGİLİ, Ege University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video-Assisted Structured Emotional Preparation Interview Group
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: 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?"
Active Comparator: Structured Emotional Preparation Interview Group
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.
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.
No Intervention: Control Group
Children in this group will receive standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored
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.
Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 16, 2026

First Submitted That Met QC Criteria

May 16, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Unknown2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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