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Not yet recruiting NCT07736664

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

No phase Interventional Preoperative Anxiety Preoperative Fear Pediatric Surgery Day Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Operating Room Transport by Walking with Parent, Operating Room Transport by Stretcher, Operating Room Transport by Battery-Powered Ride-on Car.
Who it may be relevant to
Registry conditions: Preoperative Anxiety, Preoperative Fear, Pediatric Surgery, Day Surgery. Basic parameters: 3 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Procedure Operating Room Transport by Walking with Parent
    Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
  • Procedure Operating Room Transport by Stretcher
    Participants are transported to the operating room using a stretcher.
  • Procedure Operating Room Transport by Battery-Powered Ride-on Car
    Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.

Primary outcome measures

  • Preoperative Anxiety Level [Time frame: Immediately before transfer to the operating room (preoperative period).]
Secondary outcome measures (1)
  • Preoperative Fear Level [Time frame: Immediately before transfer to the operating room (preoperative period)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07736664 · 30333

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗