Preoperative AnxietyNCT07403747
Ride-On Toy Car Use During Operating Room Transfer in Preschool Children
An observational study of Preoperative Anxiety and Emergence Delirium in Pediatric Anesthesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to determine whether the method of transfer to the operating room can reduce preoperative anxiety and postoperative emergence delirium in male children aged 3 to 7 years undergoing elective adenoidectomy and/or tonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Emergence Delirium in Pediatric Anesthesia
- What is being tested?
- Toy car and Standard Transfer
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 30 Apr 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 7 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Male pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Who may be able to join
- Male children aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
- Ability to communicate verbally
- American Society of Anesthesiologists (ASA) physical status I or II
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Presence of psychiatric disorders, genetic diseases, neurological or developmental disorders
- Chronic pain conditions or ongoing medical treatments that may affect anxiety levels
- Refusal to participate despite repeated encouragement by the investigators
- Use of additional anxiolytic interventions or medications prior to the intervention outside the study protocol
- Previous history of surgical procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
Filiz Kaya, M.D., +90312 552 60 00, filiz.kaya17@saglik.gov.tr
About this study
Official title: Evaluation of the Effects of Ride-On Toy Car Use During Operating Room Transfer on Preoperative Anxiety and Postoperative Delirium in Preschool Children
The goal of this clinical trial is to determine whether the method of transfer to the operating room can reduce preoperative anxiety and postoperative emergence delirium in male children aged 3 to 7 years undergoing elective adenoidectomy and/or tonsillectomy.
The main questions it aims to answer are:
Read more
- Does transfer using a ride-on toy car reduce preoperative anxiety compared with standard stretcher transfer?
- Does this transfer method affect the incidence and severity of postoperative emergence delirium? Researchers will compare toy car transfer with standard hospital stretcher transfer to see if the toy car transfer is associated with lower anxiety levels and reduced emergence delirium.
Participants will:
- Transfer to the operating room either using a ride-on toy car or a standard hospital stretcher
- Have preoperative anxiety assessed at predefined time points
- Be evaluated for postoperative emergence delirium during recovery
Read the detailed description
This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. The study will include male children aged 3 to 7 years who are scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Participants will be allocated into two groups. In Group 1, children will be transferred from the waiting area to the operating room using a ride-on toy car. In Group 2, children will be transferred using a standard hospital stretcher according to routine clinical practice. All other perioperative anesthesia management protocols will be standardized between groups.
Preoperative anxiety will be assessed at four predefined time points: in the waiting area (T0), immediately before transfer to the operating room (T1), in the operating room corridor (T2), and immediately before anesthesia induction (T3). Anxiety levels will be measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).
Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale at three time points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission to the post-anesthesia care unit (P2).
The primary outcome of the study is the difference in preoperative anxiety levels between the two groups. Secondary outcomes include the incidence and severity of postoperative emergence delirium. The findings of this study may contribute to the development of simple, non-pharmacological strategies to improve perioperative psychological well-being and postoperative recovery in pediatric patients.
- Being tested
- Toy car, Standard Transfer
- Keywords
- Pediatric anesthesia, Preoperative anxiety, Toy car intervention, Emergence delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toy carOther
Transfer to the operating room using a ride-on toy car.
Standard TransferOther
Transfer to the operating room using a standard hospital stretcher.
| Study group | Role | What they receive |
|---|---|---|
| Toy Car Transfer | Participants will be transferred to the operating room using a ride-on toy car. Receives: Other: Toy car | |
| Standard Stretcher Transfer | Participants will be transferred to the operating room using a standard hospital stretcher Receives: Other: Standard Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Level
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A) during the preoperative period. Preoperative anxiety will be assessed using m-YPAS, (score range 23-100) and VAS-A (score range 0-10), with higher scores indicating increased anxiety severity.
Measured: Assessments will be conducted in the waiting area, immediately before transfer to the operating room, during transport through the operating room corridor, and immediately before anesthesia induction.
Secondary outcomes (1)
Postoperative Emergence Delirium
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale (PAED; total score range 0-20). A score ≥10 will be considered indicative of emergence delirium, with higher scores reflecting greater severity.
Measured: From extubation through 30 minutes after admission to the post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Nov 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Kaya, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403747
- Sponsor's protocol ID
- TABED 1-25-1794
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including demographic characteristics, group assignment, preoperative anxiety scores, and postoperative emergence delirium scores will be shared.
Publications
Vakili R, Feizi R, Salimi Y, Mottahedi M, Rizevandi P. Play dough or balloon blowing? A clinical trial comparing creative interventions for reducing preoperative anxiety in children aged 4-8 years. BMC Pediatr. 2025 May 15;25(1):384. doi: 10.1186/s12887-025-05718-1.
PubMed 40375092Tang X, Zhang M, Yang L, Tao X, Li Y, Wang Y, Wang X, Hu X. Individual cartoon video for alleviating perioperative anxiety and reducing emergence delirium in children: a prospective randomised trial. BMJ Paediatr Open. 2023 Jul;7(1):e001854. doi: 10.1136/bmjpo-2023-001854.
PubMed 37407252Park SH, Park S, Lee S, Choi JI, Bae HB, You Y, Jeong S. Effect of transportation method on preoperative anxiety in children: a randomized controlled trial. Korean J Anesthesiol. 2020 Feb;73(1):51-57. doi: 10.4097/kja.19191. Epub 2019 Jul 15.
PubMed 31304694Pastene B, Piclet J, Praud C, Garcia K, Louis K, Schmidt C, Boyadjiev I, Boucekine M, Baumstarck K, Bezulier K, Bouvet L, Zieleskiewicz L, Leone M. Pre-operative distraction using electric ride-on cars for children undergoing elective ambulatory surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Mar 1;40(3):190-197. doi: 10.1097/EJA.0000000000001758. Epub 2022 Oct 3.
PubMed 36204923
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Ride-On Toy Car Use During Operating Room Transfer on Preoperative Anxiety and Postoperative Delirium in Preschool Children
- ClinicalTrials.gov ID
- NCT07403747
- Acronym / sponsor ID
- TABED 1-25-1794
- Keywords
- Pediatric anesthesia, Preoperative anxiety, Toy car intervention, Emergence delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 11 Feb 2026 (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 goal of this clinical trial is to determine whether the method of transfer to the operating room can reduce preoperative anxiety and postoperative emergence delirium in male children aged 3 to 7 years undergoing elective adenoidectomy and/or tonsillectomy.
The main questions it aims to answer are:
- Does transfer using a ride-on toy car reduce preoperative anxiety compared with standard stretcher transfer?
- Does this transfer method affect the incidence and severity of postoperative emergence delirium? Researchers will compare toy car transfer with standard hospital stretcher transfer to see if the toy car transfer is associated with lower anxiety levels and reduced emergence delirium.
Participants will:
- Transfer to the operating room either using a ride-on toy car or a standard hospital stretcher
- Have preoperative anxiety assessed at predefined time points
- Be evaluated for postoperative emergence delirium during recovery
Detailed description
This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. This study is designed to investigate the effect of the method of transfer to the operating room on preoperative anxiety levels and postoperative emergence delirium in pediatric patients. The study will include male children aged 3 to 7 years who are scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Participants will be allocated into two groups. In Group 1, children will be transferred from the waiting area to the operating room using a ride-on toy car. In Group 2, children will be transferred using a standard hospital stretcher according to routine clinical practice. All other perioperative anesthesia management protocols will be standardized between groups.
Preoperative anxiety will be assessed at four predefined time points: in the waiting area (T0), immediately before transfer to the operating room (T1), in the operating room corridor (T2), and immediately before anesthesia induction (T3). Anxiety levels will be measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).
Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale at three time points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission to the post-anesthesia care unit (P2).
The primary outcome of the study is the difference in preoperative anxiety levels between the two groups. Secondary outcomes include the incidence and severity of postoperative emergence delirium. The findings of this study may contribute to the development of simple, non-pharmacological strategies to improve perioperative psychological well-being and postoperative recovery in pediatric patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toy Car Transfer | – | Other: Toy carParticipants will be transferred to the operating room using a ride-on toy car. |
| Standard Stretcher Transfer | – | Other: Standard TransferParticipants will be transferred to the operating room using a standard hospital stretcher |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Male pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Key inclusion criteria (4 listed)
- Male children aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
- Ability to communicate verbally
- American Society of Anesthesiologists (ASA) physical status I or II
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (5 listed)
- Presence of psychiatric disorders, genetic diseases, neurological or developmental disorders
- Chronic pain conditions or ongoing medical treatments that may affect anxiety levels
- Refusal to participate despite repeated encouragement by the investigators
- Use of additional anxiolytic interventions or medications prior to the intervention outside the study protocol
- Previous history of surgical procedures
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 |
|---|---|---|
| Toy carTransfer to the operating room using a ride-on toy car. | Other | Toy Car Transfer |
| Standard TransferTransfer to the operating room using a standard hospital stretcher. | Other | Standard Stretcher Transfer |
Primary outcome
Preoperative Anxiety Level
Time frame: Assessments will be conducted in the waiting area, immediately before transfer to the operating room, during transport through the operating room corridor, and immediately before anesthesia induction.
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A) during the preoperative period. Preoperative anxiety will be assessed using m-YPAS, (score range 23-100) and VAS-A (score range 0-10), with higher scores indicating increased anxiety severity.
1 secondary outcome
Postoperative Emergence Delirium
Time frame: From extubation through 30 minutes after admission to the post-anesthesia care unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 40375092Vakili R, Feizi R, Salimi Y, Mottahedi M, Rizevandi P. Play dough or balloon blowing? A clinical trial comparing creative interventions for reducing preoperative anxiety in children aged 4-8 years. BMC Pediatr. 2025 May 15;25(1):384. doi: 10.1186/s12887-025-05718-1.
- Background: PubMed 37407252Tang X, Zhang M, Yang L, Tao X, Li Y, Wang Y, Wang X, Hu X. Individual cartoon video for alleviating perioperative anxiety and reducing emergence delirium in children: a prospective randomised trial. BMJ Paediatr Open. 2023 Jul;7(1):e001854. doi: 10.1136/bmjpo-2023-001854.
- Background: PubMed 31304694Park SH, Park S, Lee S, Choi JI, Bae HB, You Y, Jeong S. Effect of transportation method on preoperative anxiety in children: a randomized controlled trial. Korean J Anesthesiol. 2020 Feb;73(1):51-57. doi: 10.4097/kja.19191. Epub 2019 Jul 15.
- Background: PubMed 36204923Pastene B, Piclet J, Praud C, Garcia K, Louis K, Schmidt C, Boyadjiev I, Boucekine M, Baumstarck K, Bezulier K, Bouvet L, Zieleskiewicz L, Leone M. Pre-operative distraction using electric ride-on cars for children undergoing elective ambulatory surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Mar 1;40(3):190-197. doi: 10.1097/EJA.0000000000001758. Epub 2022 Oct 3.
- Individual participant dataSharing planned: Yes. De-identified individual participant data including demographic characteristics, group assignment, preoperative anxiety scores, and postoperative emergence delirium scores will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Anxiety and Emergence Delirium in Pediatric Anesthesia, run by Ankara City Hospital Bilkent 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 5 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filiz Kaya, M.D (+90312552 60 00, filiz.kaya17@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Level (time frame: Assessments will be conducted in the waiting area, immediately before transfer to the operating room, during transport through the operating room corridor, and immediately before anesthesia induction.). 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 NCT07403747, which also lists 4 linked publications.
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 11 Feb 2026.