- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07736664
Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: İlayda Tekelioğlu
- Numero di telefono: +905512559774
- Email: ilaydatekelioglu@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Routine Walking with Parent
Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
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Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
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Sperimentale: Stretcher Transport
Participants are transported to the operating room using a stretcher.
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Participants are transported to the operating room using a stretcher.
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Sperimentale: 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.
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Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Preoperative Anxiety Level
Lasso di tempo: Immediately before transfer to the operating room (preoperative period).
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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.
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Immediately before transfer to the operating room (preoperative period).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Preoperative Fear Level
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nurdan Akçay Didişen, PhD, Ege university
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 30333
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Informazioni su farmaci e dispositivi, documenti di studio
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