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Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children

10. august 2026 oppdatert av: İlayda Tekelioğlu, Ege University
Preoperative anxiety and fear are common among preschool children undergoing surgery and may negatively affect perioperative cooperation and postoperative recovery. This study aims to evaluate the effects of three different operating room transport methods (walking with a parent, stretcher transport, and battery-powered ride-on car transport) on preoperative anxiety and fear levels in preschool children undergoing day surgery. The findings are expected to contribute to the development of child-friendly, non-pharmacological interventions to improve the perioperative experience of children.

Studieoversikt

Detaljert beskrivelse

Preoperative anxiety is frequently observed in preschool children undergoing surgical procedures. The unfamiliar hospital environment, separation from parents, and fear of anesthesia and surgery may increase children's anxiety and fear before surgery. Elevated preoperative anxiety has been associated with poor cooperation during anesthesia induction, increased postoperative pain, maladaptive behavioral changes, and delayed recovery.

Several non-pharmacological interventions have been developed to reduce children's anxiety before surgery. Among these, distraction techniques and child-friendly environmental modifications have shown promising results. Transporting children to the operating room using battery-powered ride-on cars has recently emerged as an innovative distraction strategy that may transform the transport process into a playful experience.

This controlled study aims to compare three different operating room transport methods in preschool children undergoing elective day surgery: routine transport by walking with a parent, transport by stretcher, and transport using a battery-powered ride-on car. Preoperative anxiety and fear will be assessed using validated pediatric assessment tools before surgery. The study findings may provide evidence for the effectiveness of child-friendly transport methods in reducing preoperative anxiety and fear and support the implementation of non-pharmacological interventions in pediatric surgical care.

Studietype

Intervensjonell

Registrering (Antatt)

66

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Children aged 3-6 years (36-72 months)
  • Scheduled to undergo elective surgery in the Department of Pediatric Surgery
  • Able to communicate appropriately for their age
  • Have sufficient cognitive development to respond to the study assessment scales
  • Child and parent/legal guardian are able to speak and understand Turkish
  • Written informed consent obtained from the child's legal guardian (and child assent obtained when appropriate)

Exclusion Criteria:

  • Presence of visual, hearing, or communication impairments that could interfere with study participation
  • Receipt of premedication requiring sedation due to an emergency condition
  • Presence of severe pain that could affect anxiety assessment before surgery
  • Inability to safely use the battery-powered ride-on car because of physical or mobility limitations before surgery
  • Withdrawal of consent by the child's legal guardian or the child's unwillingness to continue participation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Routine Walking with Parent
Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
Eksperimentell: Stretcher Transport
Participants are transported to the operating room using a stretcher.
Participants are transported to the operating room using a stretcher.
Eksperimentell: Battery-Powered Ride-on Car Transport
Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.
Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Preoperative Anxiety Level
Tidsramme: Immediately before transfer to the operating room (preoperative period).
Preoperative anxiety levels will be assessed using the Children's Anxiety Scale-State (CAS-S), a visual thermometer-like scale with scores ranging from 0 to 10. Higher scores indicate higher levels of state anxiety. Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
Immediately before transfer to the operating room (preoperative period).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Preoperative Fear Level
Tidsramme: Immediately before transfer to the operating room (preoperative period)
Preoperative fear levels will be assessed using the Children's Fear Scale (CFS), which consists of five facial expressions and is scored from 0 to 4. A score of 0 indicates no fear, while a score of 4 indicates severe fear. Higher scores indicate higher levels of fear. Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
Immediately before transfer to the operating room (preoperative period)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: Nurdan Akçay Didişen, PhD, Ege university

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

31. juli 2026

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

31. juli 2027

Datoer for studieregistrering

Først innsendt

26. juli 2026

Først innsendt som oppfylte QC-kriteriene

26. juli 2026

Først lagt ut (Faktiske)

30. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

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