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

NCT07602621 | Not Yet Recruiting DMC

• 1 other identifier: Unknown2
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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
• Receive the assigned intervention before subcutaneous procedures
• Complete emotional expression assessments before and after the intervention and after the procedure
• Participate in evaluations during three different chemotherapy treatment sessions over a 30-day period
• Have their procedure duration and crying time recorded during each subcutaneous procedure

Conditions

Emotional Expression; Duration of sc Treatment; Duration of Crying

Keywords

emotional expression; subcutaneous tretament; pediatric nursing; video assisted intervention

Outcome Measures

Primary Outcomes (1)

• Emotional Expression

  The scale is used to assess the anxiety children experience during medical procedures.

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

Secondary Outcomes (2)

• duration of SC process

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

• Duration of crying

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

Study Arms (3)

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?"

Other: Video-Assisted Structured Emotional Preparation

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.

Other: Structured Emotional Preparation

Control Group

NO INTERVENTION

Children in this group will receive standard clinical care.

Interventions

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?"

Video-Assisted Structured Emotional Preparation Interview Group

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.

Structured Emotional Preparation Interview Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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 Expression Scale (CEES) 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share