The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre
1 other identifier
interventional
118
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started May 2023
1 active site
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
Study Start
First participant enrolled
May 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2024
CompletedFirst Submitted
Initial submission to the registry
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedMarch 12, 2024
March 1, 2024
10 months
March 4, 2024
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Perioperative anxiety
Yale Modified Preoperative Anxiety Scale Child Form
30 minutes
Study Arms (2)
Intervention group
EXPERIMENTALTransfer to the operating theatre with an electric ride-on car
Controlled group
NO INTERVENTIONTransfer to the operating theatre with a paediatric trolley
Interventions
The children in the experimental group will be transported to the operating theatre by a electric ride-on car.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- having cognitive or physical disabilities that may prevent riding a electric ride-on car
- premedication before surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uşak Universitylead
Study Sites (1)
Usak University Training and Research Hospital
Uşak, 64100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2024
First Posted
March 12, 2024
Study Start
May 2, 2023
Primary Completion
February 15, 2024
Study Completion
February 15, 2024
Last Updated
March 12, 2024
Record last verified: 2024-03