Pediatric LeukemiaNCT07602621
Video-Assisted Emotional Preparation and Emotional Expression During Subcutaneous Procedures in Children With Cancer
A study testing Video-Assisted Structured Emotional Preparation and Structured Emotional Preparation in people with Pediatric Leukemia, run by Ege University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Pediatric Leukemia
- What is being tested?
- Video-Assisted Structured Emotional Preparation and Structured Emotional Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
About this study
Official title: 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:
Read more
- 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
Read the 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:
- 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.
- Conditions
- Pediatric Leukemia
- Being tested
- Video-Assisted Structured Emotional Preparation, Structured Emotional Preparation
- Keywords
- emotional expression, subcutaneous tretament, pediatric nursing, video assisted intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Structured Emotional PreparationOther
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 PreparationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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?" Receives: 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. Receives: Other: Structured Emotional Preparation |
| Control Group | No intervention | Children in this group will receive standard clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored
Secondary outcomes (2)
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.
Measured: Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored
Duration of crying
The duration of crying in children during subcutaneous injection will be recorded in accordance with clinical protocol.
Measured: Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric LeukemiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA ARDAHAN SEVGİLİ, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602621
- Sponsor's protocol ID
- Unknown2
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-Assisted Emotional Preparation on Emotional Expression in Children With Cancer Undergoing Subcutaneous Procedures
- ClinicalTrials.gov ID
- NCT07602621
- Acronym / sponsor ID
- Unknown2
- Conditions
- Pediatric Leukemia
- Keywords
- emotional expression, subcutaneous tretament, pediatric nursing, video assisted intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video-Assisted Structured Emotional Preparation Interview Group | Experimental | Other: Video-Assisted Structured Emotional PreparationIn 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 Interview Group | Active comparator | Other: Structured Emotional PreparationIn 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. |
| Control Group | No intervention | –Children in this group will receive standard clinical care. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Assisted Structured Emotional PreparationIn 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 Interview Group |
| Structured Emotional PreparationIn 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. | Other | Structured Emotional Preparation Interview Group |
Primary outcome
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.
2 secondary outcomes
duration of SC process
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Assisted Structured Emotional Preparation and Structured Emotional Preparation in people with Pediatric Leukemia, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Expression (time frame: Subcutaneous treatments to be administered on days 0, 15, and 30 will be monitored). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.