NCT07736664

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 31, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 26, 2026

Last Update Submit

July 26, 2026

Conditions

Keywords

Preschool ChildrenOperating Room TransportBattery-Powered Ride-on CarStretcher TransportPreoperative AnxietyPreoperative FearNon-pharmacological InterventionPediatric SurgeryDay Surgery

Outcome Measures

Primary Outcomes (1)

  • Preoperative Anxiety Level

    Preoperative anxiety levels will be assessed using the Children's State Anxiety Scale (CSAS) and 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).

Secondary Outcomes (1)

  • Preoperative Fear Level

    Immediately before transfer to the operating room (preoperative period)

Study Arms (3)

Routine Walking with Parent

ACTIVE COMPARATOR

Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.

Procedure: Operating Room Transport by Walking with Parent

Stretcher Transport

EXPERIMENTAL

Participants are transported to the operating room using a stretcher.

Procedure: Operating Room Transport by Stretcher

Battery-Powered Ride-on Car Transport

EXPERIMENTAL

Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.

Procedure: Operating Room Transport by Battery-Powered Ride-on Car

Interventions

Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.

Routine Walking with Parent

Participants are transported to the operating room using a stretcher.

Stretcher Transport

Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.

Battery-Powered Ride-on Car Transport

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Nurdan Akçay Didişen, PhD

    Ege University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İlayda Tekelioğlu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of three parallel groups. The intervention consists of transportation to the operating room by walking with a parent, stretcher, or battery-powered ride-on car. Preoperative anxiety and fear are compared between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Student

Study Record Dates

First Submitted

July 26, 2026

First Posted

July 30, 2026

Study Start

July 31, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share