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NCT Number: NCT07403747

Ride-On Toy Car Use During Operating Room Transfer in Preschool Children

The goal of this clinical trial is to determine whether the method of transfer to the operating room can reduce preoperative anxiety and postoperative emergence delirium in male children aged 3 to 7 years undergoing elective adenoidectomy and/or tonsillectomy.

The main questions it aims to answer are:

* Does transfer using a ride-on toy car reduce preoperative anxiety compared with standard stretcher transfer? * Does this transfer method affect the incidence and severity of postoperative emergence delirium? Researchers will compare toy car transfer with standard hospital stretcher transfer to see if the toy car transfer is associated with lower anxiety levels and reduced emergence delirium.

Participants will:

* Transfer to the operating room either using a ride-on toy car or a standard hospital stretcher * Have preoperative anxiety assessed at predefined time points * Be evaluated for postoperative emergence delirium during recovery

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Key information

Age range

3 year–7 year

Sex eligibility

Male

Study type

Observational

Primary location

About this study

This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. The study will include male children aged 3 to 7 years who are scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.

Participants will be allocated into two groups. In Group 1, children will be transferred from the waiting area to the operating room using a ride-on toy car. In Group 2, children will be transferred using a standard hospital stretcher according to routine clinical practice. All other perioperative anesthesia management protocols will be standardized between groups.

Preoperative anxiety will be assessed at four predefined time points: in the waiting area (T0), immediately before transfer to the operating room (T1), in the operating room corridor (T2), and immediately before anesthesia induction (T3). Anxiety levels will be measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).

Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale at three time points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission to the post-anesthesia care unit (P2).

The primary outcome of the study is the difference in preoperative anxiety levels between the two groups. Secondary outcomes include the incidence and severity of postoperative emergence delirium. The findings of this study may contribute to the development of simple, non-pharmacological strategies to improve perioperative psychological well-being and postoperative recovery in pediatric patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male children aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
  • Ability to communicate verbally
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Written informed consent obtained from a parent or legal guardian

Exclusion criteria

  • Presence of psychiatric disorders, genetic diseases, neurological or developmental disorders
  • Chronic pain conditions or ongoing medical treatments that may affect anxiety levels
  • Refusal to participate despite repeated encouragement by the investigators
  • Use of additional anxiolytic interventions or medications prior to the intervention outside the study protocol
  • Previous history of surgical procedures

Treatment and study plan

Toy car

Other

Transfer to the operating room using a ride-on toy car.

Standard Transfer

Other

Transfer to the operating room using a standard hospital stretcher.

Primary outcomes

  1. Preoperative Anxiety Level

    Time frame: Assessments will be conducted in the waiting area, immediately before transfer to the operating room, during transport through the operating room corridor, and immediately before anesthesia induction.

    Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A) during the preoperative period. Preoperative anxiety will be assessed using m-YPAS, (score range 23-100) and VAS-A (score range 0-10), with higher scores indicating increased anxiety severity.

Secondary outcomes

  1. Postoperative Emergence Delirium

    Time frame: From extubation through 30 minutes after admission to the post-anesthesia care unit

    Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale (PAED; total score range 0-20). A score ≥10 will be considered indicative of emergence delirium, with higher scores reflecting greater severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Filiz Kaya, M.D

CONTACT

[email protected]

+90312552 60 00

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Evaluation of the Effects of Ride-On Toy Car Use During Operating Room Transfer on Preoperative Anxiety and Postoperative Delirium in Preschool Children

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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