AnxietyNCT03018145
Effect of Transportation Method on Preoperative Anxiety in Children
A study testing Wagon and Standard stretcher car in people with Anxiety and Child Behavior, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Child Behavior
- What is being tested?
- Wagon and Standard stretcher car
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2017to 20 Apr 2017
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- American Society of Anesthesiologist physical status I
- scheduled for elective surgery under general anesthesia
Who cannot join
- history of anesthesia or surgery
- developmental delay
- weighing over than 38kg
- severe pain
- administrated psychotomimetic drug
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety.
- Conditions
- Anxiety, Child Behavior
- Being tested
- Wagon, Standard stretcher car
- Medical subject headings
- Anxiety Disorders, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WagonDevice
Also called wagonTM, Step 2 company
Standard stretcher carDevice
Also called Stryker, Stryker medical
| Study group | Role | What they receive |
|---|---|---|
| Standard stretcher group | Experimental | Use a standard stretcher car as a transporting method in the operating room Receives: Device: Standard stretcher car |
| Wagon group | Active comparator | Use a wagon as a transporting method in the operating room Receives: Device: Wagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale
Measured: From entry of operating room to induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start12 Jan 2017
- Primary completion25 Mar 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seongtae Jeong, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018145
- Sponsor's protocol ID
- CNUH-2016-185
- Status last verified
- Nov 2017
- First submitted
- 10 Jan 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transportation Method on Preoperative Anxiety in Children
- ClinicalTrials.gov ID
- NCT03018145
- Acronym / sponsor ID
- CNUH-2016-185
- Conditions
- Anxiety, Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 25 Mar 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 11 Jan 2017 (estimated)
- 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.
To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard stretcher group | Experimental | Device: Standard stretcher carUse a standard stretcher car as a transporting method in the operating room |
| Wagon group | Active comparator | Device: WagonUse a wagon as a transporting method in the operating room |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist physical status I
- scheduled for elective surgery under general anesthesia
Key exclusion criteria (5 listed)
- history of anesthesia or surgery
- developmental delay
- weighing over than 38kg
- severe pain
- administrated psychotomimetic drug
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 |
|---|---|---|
| WagonAlso: wagonTM, Step 2 company | Device | Wagon group |
| Standard stretcher carAlso: Stryker, Stryker medical | Device | Standard stretcher group |
Primary outcome
Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale
Time frame: From entry of operating room to induction of anesthesia
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 2 Jan 2018.
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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 Wagon and Standard stretcher car in people with Anxiety and Child Behavior, run by Chonnam National University Hospital at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 2 Jan 2018. 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 South Korea. 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?
Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale (time frame: From entry of operating room to induction of anesthesia). 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 2 Jan 2018.