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NCT06303843 Clinical Trial

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

Anxiety Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06303843
Other study ID # 13.04.2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2023
Est. completion date February 15, 2024

Study information
Verified date March 2024
Source Usak University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. Translated with DeepL.com (free version)

Recruitment information / eligibility
Status Completed
Enrollment 118
Est. completion date February 15, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 10 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Turkey Usak University Training and Research Hospital Usak

Sponsors (1)
Lead Sponsor Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perioperative anxiety Yale Modified Preoperative Anxiety Scale Child Form 30 minutes
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