Effects of Cartoons and Mobile Games on Preoperative Anxiety and Fear in Children With Appendicitis: An RCT
Apandisit Tanısı Ile Cerrahi Servise Yatırılan Çocuklarda Preoperatif Kaygı ve Korkunun Azaltılmasında Çizgi Film ve Mobil Oyunların Etkisi: Randomize Kontrollü Bir Araştırma
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Preoperative anxiety and fear are common among children undergoing surgery and may negatively affect both perioperative outcomes and postoperative recovery. Non-pharmacological, atraumatic care interventions are recommended to minimize psychological distress in pediatric patients. Among these interventions, distraction techniques such as cartoon viewing and mobile game playing are widely used due to their practicality and accessibility.
This randomized controlled trial aims to compare the effects of cartoon viewing and mobile game playing on preoperative anxiety and fear levels in children aged 7-12 years diagnosed with appendicitis and admitted to a pediatric surgery unit. Participants will be randomly assigned to one of three groups: a cartoon intervention group, a mobile game intervention group, or a control group receiving routine care.
Children in the intervention groups will receive a 10-minute distraction intervention (cartoon viewing or mobile game playing) prior to surgery, while the control group will receive standard clinical care without any additional intervention. Anxiety and fear levels will be assessed before and after the intervention using validated measurement tools.
This study is expected to provide evidence-based data on the effectiveness of simple, low-cost, and easily applicable non-pharmacological interventions in reducing preoperative anxiety and fear in children. The findings may contribute to the development of atraumatic care practices and improve pediatric surgical care outcomes.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Eda Emine Yetkin, MSc Student
- Telefoonnummer: +905 30 137 58 79
- E-mail: edaayetkinn@outlook.com
Studie Locaties
-
-
-
Ankara, Turkije (Türkiye)
- Werving
- Ankara Bilkent City Hospital
-
Contact:
- Pediatric Surgery Service (4A and 4B Pediatric Surgery Service
- Telefoonnummer: 0312 552 60 00
- E-mail: ankarasehir@saglik.gov.tr
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Control Group
Participants in this group will receive standard hospital care and routine preoperative preparation without any additional digital distraction interventions.
|
|
|
Experimenteel: Cartoon Group
Participants in this group will be exposed to a cartoon-assisted distraction intervention designed to explain the surgical process and reduce anxiety before surgery.
|
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.
|
|
Experimenteel: Mobile Game Group
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.
|
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).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Preoperative Anxiety Level
Tijdsspanne: Baseline (upon admission to the pediatric surgery inpatient unit prior to the intervention) and post-intervention (immediately before transfer to the operating room).
|
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
Tijdsspanne: Baseline (upon admission to the pediatric surgery inpatient unit prior to the intervention) and post-intervention (immediately before transfer to the operating room).
|
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).
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Heart Rate
Tijdsspanne: Measured at two time points: baseline (pre-intervention) and immediately post-intervention.
|
The participants' heart rate will be measured to evaluate physiological stability.
The values will be recorded in beats per minute (bpm).
|
Measured at two time points: baseline (pre-intervention) and immediately post-intervention.
|
|
Blood Pressure
Tijdsspanne: Measured at two time points: baseline (pre-intervention) and immediately post-intervention.
|
The participants' systolic and diastolic blood pressure values will be measured.
The values will be recorded in millimeters of mercury (mmHg).
|
Measured at two time points: baseline (pre-intervention) and immediately post-intervention.
|
|
Oxygen Saturation
Tijdsspanne: Measured at two time points: baseline (pre-intervention) and immediately post-intervention.
|
The participants' peripheral oxygen saturation (SpO2) levels will be monitored.
The values will be recorded as a percentage (%).
|
Measured at two time points: baseline (pre-intervention) and immediately post-intervention.
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TABED 1/1735/2025
- TYL-2026-2917 (Ander subsidie-/financieringsnummer: Ankara Yildirim Beyazit University BAP Department)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .