Preoperative AnxietyNCT07736664
Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children
A study testing Operating Room Transport by Walking with Parent, Operating Room Transport by Stretcher and Operating Room Transport by Battery-Powered Ride-on Car in people with Preoperative Anxiety and Preoperative Fear, run by Ege University.
Trial summary
Preoperative anxiety and fear are common among preschool children undergoing surgery and may negatively affect perioperative cooperation and postoperative recovery. This study aims to evaluate the effects of three different operating room transport methods (walking with a parent, stretcher transport, and… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Preoperative Anxiety, Preoperative Fear, Pediatric Surgery
- What is being tested?
- Operating Room Transport by Walking with Parent, Operating Room Transport by Stretcher and Operating Room Transport by Battery-Powered Ride-on Car
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 31 Jul 2027
- Phase
- Interventional
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-6 years (36-72 months)
- Scheduled to undergo elective surgery in the Department of Pediatric Surgery
- Able to communicate appropriately for their age
- Have sufficient cognitive development to respond to the study assessment scales
- Child and parent/legal guardian are able to speak and understand Turkish
- Written informed consent obtained from the child's legal guardian (and child assent obtained when appropriate)
Who cannot join
- Presence of visual, hearing, or communication impairments that could interfere with study participation
- Receipt of premedication requiring sedation due to an emergency condition
- Presence of severe pain that could affect anxiety assessment before surgery
- Inability to safely use the battery-powered ride-on car because of physical or mobility limitations before surgery
- Withdrawal of consent by the child's legal guardian or the child's unwillingness to continue participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Preoperative anxiety and fear are common among preschool children undergoing surgery and may negatively affect perioperative cooperation and postoperative recovery. This study aims to evaluate the effects of three different operating room transport methods (walking with a parent, stretcher transport, and battery-powered ride-on car transport) on preoperative anxiety and fear levels in preschool children undergoing day surgery. The findings are expected to contribute to the development of child-friendly, non-pharmacological interventions to improve the perioperative experience of children.
Read the detailed description
Preoperative anxiety is frequently observed in preschool children undergoing surgical procedures. The unfamiliar hospital environment, separation from parents, and fear of anesthesia and surgery may increase children's anxiety and fear before surgery. Elevated preoperative anxiety has been associated with poor cooperation during anesthesia induction, increased postoperative pain, maladaptive behavioral changes, and delayed recovery.
Several non-pharmacological interventions have been developed to reduce children's anxiety before surgery. Among these, distraction techniques and child-friendly environmental modifications have shown promising results. Transporting children to the operating room using battery-powered ride-on cars has recently emerged as an innovative distraction strategy that may transform the transport process into a playful experience.
This controlled study aims to compare three different operating room transport methods in preschool children undergoing elective day surgery: routine transport by walking with a parent, transport by stretcher, and transport using a battery-powered ride-on car. Preoperative anxiety and fear will be assessed using validated pediatric assessment tools before surgery. The study findings may provide evidence for the effectiveness of child-friendly transport methods in reducing preoperative anxiety and fear and support the implementation of non-pharmacological interventions in pediatric surgical care.
- Being tested
- Operating Room Transport by Walking with Parent, Operating Room Transport by Stretcher, Operating Room Transport by Battery-Powered Ride-on Car
- Keywords
- Preschool Children, Operating Room Transport, Battery-Powered Ride-on Car, Stretcher Transport, Preoperative Anxiety, Preoperative Fear, Non-pharmacological Intervention, Pediatric Surgery, Day Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operating Room Transport by Walking with ParentProcedure or surgery
Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
Operating Room Transport by StretcherProcedure or surgery
Participants are transported to the operating room using a stretcher.
Operating Room Transport by Battery-Powered Ride-on CarProcedure or surgery
Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Routine Walking with Parent | Active comparator | Participants are transported to the operating room by walking with a parent according to the hospital's routine practice. Receives: Procedure: Operating Room Transport by Walking with Parent |
| Stretcher Transport | Experimental | Participants are transported to the operating room using a stretcher. Receives: Procedure: Operating Room Transport by Stretcher |
| Battery-Powered Ride-on Car Transport | Experimental | Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher. Receives: Procedure: Operating Room Transport by Battery-Powered Ride-on Car |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Level
Preoperative anxiety levels will be assessed using the Children's Anxiety Scale-State (CAS-S), a visual thermometer-like scale with scores ranging from 0 to 10. Higher scores indicate higher levels of state anxiety. Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
Measured: Immediately before transfer to the operating room (preoperative period).
Secondary outcomes (1)
Preoperative Fear Level
Preoperative fear levels will be assessed using the Children's Fear Scale (CFS), which consists of five facial expressions and is scored from 0 to 4. A score of 0 indicates no fear, while a score of 4 indicates severe fear. Higher scores indicate higher levels of fear. Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
Measured: Immediately before transfer to the operating room (preoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of three parallel groups. The intervention consists of transportation to the operating room by walking with a parent, stretcher, or battery-powered ride-on car. Preoperative anxiety and fear are compared between groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlayda Tekelioğlu, Ege University
- Investigators
- Nurdan Akçay Didişen, PhD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736664
- Sponsor's protocol ID
- 30333
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children
- ClinicalTrials.gov ID
- NCT07736664
- Acronym / sponsor ID
- 30333
- Keywords
- Preschool Children, Operating Room Transport, Battery-Powered Ride-on Car, Stretcher Transport, Preoperative Anxiety, Preoperative Fear, Non-pharmacological Intervention, Pediatric Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 30 Jul 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.
Preoperative anxiety and fear are common among preschool children undergoing surgery and may negatively affect perioperative cooperation and postoperative recovery. This study aims to evaluate the effects of three different operating room transport methods (walking with a parent, stretcher transport, and battery-powered ride-on car transport) on preoperative anxiety and fear levels in preschool children undergoing day surgery. The findings are expected to contribute to the development of child-friendly, non-pharmacological interventions to improve the perioperative experience of children.
Detailed description
Preoperative anxiety is frequently observed in preschool children undergoing surgical procedures. The unfamiliar hospital environment, separation from parents, and fear of anesthesia and surgery may increase children's anxiety and fear before surgery. Elevated preoperative anxiety has been associated with poor cooperation during anesthesia induction, increased postoperative pain, maladaptive behavioral changes, and delayed recovery.
Several non-pharmacological interventions have been developed to reduce children's anxiety before surgery. Among these, distraction techniques and child-friendly environmental modifications have shown promising results. Transporting children to the operating room using battery-powered ride-on cars has recently emerged as an innovative distraction strategy that may transform the transport process into a playful experience.
This controlled study aims to compare three different operating room transport methods in preschool children undergoing elective day surgery: routine transport by walking with a parent, transport by stretcher, and transport using a battery-powered ride-on car. Preoperative anxiety and fear will be assessed using validated pediatric assessment tools before surgery. The study findings may provide evidence for the effectiveness of child-friendly transport methods in reducing preoperative anxiety and fear and support the implementation of non-pharmacological interventions in pediatric surgical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Participants are assigned to one of three parallel groups. The intervention consists of transportation to the operating room by walking with a parent, stretcher, or battery-powered ride-on car. Preoperative anxiety and fear are compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Routine Walking with Parent | Active comparator | Procedure: Operating Room Transport by Walking with ParentParticipants are transported to the operating room by walking with a parent according to the hospital's routine practice. |
| Stretcher Transport | Experimental | Procedure: Operating Room Transport by StretcherParticipants are transported to the operating room using a stretcher. |
| Battery-Powered Ride-on Car Transport | Experimental | Procedure: Operating Room Transport by Battery-Powered Ride-on CarParticipants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 3-6 years (36-72 months)
- Scheduled to undergo elective surgery in the Department of Pediatric Surgery
- Able to communicate appropriately for their age
- Have sufficient cognitive development to respond to the study assessment scales
- Child and parent/legal guardian are able to speak and understand Turkish
Key exclusion criteria (5 listed)
- Presence of visual, hearing, or communication impairments that could interfere with study participation
- Receipt of premedication requiring sedation due to an emergency condition
- Presence of severe pain that could affect anxiety assessment before surgery
- Inability to safely use the battery-powered ride-on car because of physical or mobility limitations before surgery
- Withdrawal of consent by the child's legal guardian or the child's unwillingness to continue participation
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 |
|---|---|---|
| Operating Room Transport by Walking with ParentParticipants are transported to the operating room by walking with a parent according to the hospital's routine practice. | Procedure or surgery | Routine Walking with Parent |
| Operating Room Transport by StretcherParticipants are transported to the operating room using a stretcher. | Procedure or surgery | Stretcher Transport |
| Operating Room Transport by Battery-Powered Ride-on CarParticipants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher. | Procedure or surgery | Battery-Powered Ride-on Car Transport |
Primary outcome
Preoperative Anxiety Level
Time frame: Immediately before transfer to the operating room (preoperative period).
Preoperative anxiety levels will be assessed using the Children's Anxiety Scale-State (CAS-S), a visual thermometer-like scale with scores ranging from 0 to 10. Higher scores indicate higher levels of state anxiety. Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
1 secondary outcome
Preoperative Fear Level
Time frame: Immediately before transfer to the operating room (preoperative period)
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Nurdan Akçay Didişen, PhD principal investigator
Ege University
Questions about this trial
What is this clinical trial studying?
A study testing Operating Room Transport by Walking with Parent, Operating Room Transport by Stretcher and Operating Room Transport by Battery-Powered Ride-on Car in people with Preoperative Anxiety and Preoperative Fear, run by Ege University.
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 6 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 İlayda Tekelioğlu (+905512559774, ilaydatekelioglu@gmail.com), 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: Immediately before transfer to the operating room (preoperative period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.