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

NCT ID: NCT06303843

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2024-02-15

Brief Summary

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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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Detailed Description

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Conditions

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Anxiety Preoperative Anxiety Pediatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Transfer to the operating theatre with an electric ride-on car

Group Type EXPERIMENTAL

Transfer with an electric ride-on car

Intervention Type OTHER

The children in the experimental group will be transported to the operating theatre by a electric ride-on car.

Controlled group

Transfer to the operating theatre with a paediatric trolley

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uşak University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Usak University Training and Research Hospital

Uşak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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13.04.2023

Identifier Type: -

Identifier Source: org_study_id

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