The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre

March 4, 2024 updated by: Uşak University

The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre on Preoperative Anxiety in Children Undergoing Elective Ambulatory Surgery: A Randomised Controlled Trial

The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group.

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Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Usak, Turkey, 64100
        • Usak University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being between 2-10 years old,
  • Less than 35 kg (according to the manufacturer's instructions for ride-on battery cars),
  • To undergo elective surgery,
  • Volunteering to participate in the study.

Exclusion Criteria:

  • having cognitive or physical disabilities that may prevent riding a electric ride-on car
  • premedication before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Transfer to the operating theatre with an electric ride-on car
Other: Transfer with an electric ride-on car
The children in the experimental group will be transported to the operating theatre by a electric ride-on car.
No Intervention: Controlled group
Transfer to the operating theatre with a paediatric trolley

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative anxiety
Time Frame: 30 minutes
Yale Modified Preoperative Anxiety Scale Child Form
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.04.2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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