NCT07640230

Brief Summary

his study aims to evaluate the effects of cartoon viewing and mobile game playing on preoperative anxiety and fear levels in children aged 7-12 years who are hospitalized for appendicitis surgery. The study is designed as a randomized controlled trial with three groups: a cartoon group, a mobile game group, and a control group receiving routine care. Children in the intervention groups will watch a cartoon or play a mobile game for 10 minutes before surgery. Anxiety and fear levels will be measured using validated scales before and after the intervention. The findings of this study are expected to contribute to atraumatic care practices by providing simple and effective non-pharmacological methods to reduce preoperative anxiety and fear in children.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

May 6, 2026

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Preoperative Anxiety Level

    The Modified Yale Preoperative Anxiety Scale (m-YPAS) will be used. This scale provides an observational assessment across five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents). Total scores range from 5 to 22, with higher scores indicating higher levels of anxiety.

    Baseline (upon admission to the pediatric surgery inpatient unit prior to the intervention) and post-intervention (immediately before transfer to the operating room).

  • Children's Fear Level

    The Children's Fear Scale (CFS) will be used. This scale consists of five different facial expressions scored between 0 and 4. A score of 0 indicates "no anxiety/fear," whereas a score of 4 indicates "the highest level of fear."

    Baseline (upon admission to the pediatric surgery inpatient unit prior to the intervention) and post-intervention (immediately before transfer to the operating room).

Secondary Outcomes (3)

  • Heart Rate

    Measured at two time points: baseline (pre-intervention) and immediately post-intervention.

  • Blood Pressure

    Measured at two time points: baseline (pre-intervention) and immediately post-intervention.

  • Oxygen Saturation

    Measured at two time points: baseline (pre-intervention) and immediately post-intervention.

Study Arms (3)

Control Group

NO INTERVENTION

Participants in this group will receive standard hospital care and routine preoperative preparation without any additional digital distraction interventions.

Cartoon Group

EXPERIMENTAL

Participants in this group will be exposed to a cartoon-assisted distraction intervention designed to explain the surgical process and reduce anxiety before surgery.

Behavioral: Cartoon-Assisted Distraction (Şüko Ameliyat Oluyor)

Mobile Game Group

EXPERIMENTAL

Participants in this group will engage in age-appropriate mobile games on a tablet computer as a digital distraction intervention prior to their surgical procedure.

Behavioral: Mobile Game

Interventions

Participants will watch the cartoon titled "Şüko is Having Surgery," which explains the surgical process in child-friendly language, on an iPad Mini 6 with headphones for 10 minutes.

Cartoon Group
Mobile GameBEHAVIORAL

Children will be asked to play a game of their choice for 10 minutes on a tablet from among games selected according to their age group and PEGI standards (Head Ball 2, Subway Surfers, and Magic Tiles 3).

Mobile Game Group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being hospitalized in the Pediatric Surgery Service with a diagnosis of appendicitis.
  • Being between the ages of 7 and 12 years.
  • Voluntary consent/assent from both the child and their parents to participate in the study.
  • Absence of any visual, auditory, or cognitive problems that prevent communication.
  • Not having received any analgesics before the intervention.

You may not qualify if:

  • Refusal to participate in the study voluntarily.
  • Having a condition that prevents communication due to vision, hearing, speech, or mental health status.
  • Being in an agitated state or unable to cooperate.
  • Having received analgesics due to pain before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AppendicitisDisease

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Eda Emine Yetkin, MSc Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

June 10, 2026

Study Start

October 10, 2025

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations