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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorEge University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Video-Assisted Structured Emotional Preparation

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Video-Assisted Structured Emotional Preparation Interview GroupExperimental treatment 1 intervention
Group B: Structured Emotional Preparation Interview GroupActive comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored

Secondary outcomes

1

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.

Time frame
Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored
2

Duration of crying

The duration of crying in children during subcutaneous injection will be recorded in accordance with clinical protocol.

Time frame
Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: