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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Eda Emine Yetkin, MSc Student
- Telefonnummer: +905 30 137 58 79
- E-post: edaayetkinn@outlook.com
Studiesteder
-
-
-
Ankara, Tyrkia (Türkiye)
- Rekruttering
- Ankara Bilkent City Hospital
-
Ta kontakt med:
- Pediatric Surgery Service (4A and 4B Pediatric Surgery Service
- Telefonnummer: 0312 552 60 00
- E-post: ankarasehir@saglik.gov.tr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Group
Participants in this group will receive standard hospital care and routine preoperative preparation without any additional digital distraction interventions.
|
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Preoperative Anxiety Level
Tidsramme: 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
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TABED 1/1735/2025
- TYL-2026-2917 (Annet stipend/finansieringsnummer: Ankara Yildirim Beyazit University BAP Department)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .