AnxietyNCT06303843
The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre
A study testing Transfer with an electric ride-on car in people with Anxiety and Preoperative Anxiety, run by Uşak University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Preoperative Anxiety, Pediatric Surgery
- What is being tested?
- Transfer with an electric ride-on car
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- having cognitive or physical disabilities that may prevent riding a electric ride-on car
- premedication before surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak University Training and Research Hospital
Uşak, 64100
About this study
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
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)
- Conditions
- Anxiety, Preoperative Anxiety, Pediatric Surgery
- Being tested
- Transfer with an electric ride-on car
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer with an electric ride-on carOther
The children in the experimental group will be transported to the operating theatre by a electric ride-on car.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Transfer to the operating theatre with an electric ride-on car Receives: Other: Transfer with an electric ride-on car |
| Controlled group | No intervention | Transfer to the operating theatre with a paediatric trolley |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative anxiety
Yale Modified Preoperative Anxiety Scale Child Form
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start2 May 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303843
- Sponsor's protocol ID
- 13.04.2023
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arikan B, Temiz B. The effect of electric ride-on cars use during transport to the operating room on preoperative anxiety in children: a cluster randomized controlled trial. Pediatr Surg Int. 2026 Jan 5;42(1):60. doi: 10.1007/s00383-025-06291-5.
PubMed 41489634
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06303843
- Acronym / sponsor ID
- 13.04.2023
- Conditions
- Anxiety, Preoperative Anxiety, Pediatric Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Transfer with an electric ride-on carTransfer to the operating theatre with an electric ride-on car |
| Controlled group | No intervention | –Transfer to the operating theatre with a paediatric trolley |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- having cognitive or physical disabilities that may prevent riding a electric ride-on car
- premedication before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfer with an electric ride-on carThe children in the experimental group will be transported to the operating theatre by a electric ride-on car. | Other | Intervention group |
Primary outcome
Perioperative anxiety
Time frame: 30 minutes
Yale Modified Preoperative Anxiety Scale Child Form
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 41489634Arikan B, Temiz B. The effect of electric ride-on cars use during transport to the operating room on preoperative anxiety in children: a cluster randomized controlled trial. Pediatr Surg Int. 2026 Jan 5;42(1):60. doi: 10.1007/s00383-025-06291-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfer with an electric ride-on car in people with Anxiety and Preoperative Anxiety, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative anxiety (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06303843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.