Effect of Transportation Method on Preoperative Anxiety i... | NCT03018145

Studies
Effect of Transportation Method on Preoperative Anxiety in Children

NCT03018145

Sponsor

Chonnam National University Hospital

Status

Completed

Last Update Posted

Jan 2, 2018Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Anxiety
Child Behavior

Interventions

Wagon
Standard stretcher car

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2017Actual

Primary Completion Date

Mar 25, 2017Actual

Completion Date

Apr 20, 2017Actual

First Submitted Date

Jan 10, 2017

First Submission Date that Met QC Criteria

Jan 10, 2017

First Posted Date

Jan 11, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2017

Last Update Posted Date

Jan 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seongtae Jeong, Department of Anesthesiolgoy and Pain Medicine, Chonnam National University HospitalPrincipal Investigator

Lead Sponsor

Chonnam National University HospitalOTHER

Collaborators

Not provided

Description Module

Brief Summary

To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard stretcher group	Experimental	Use a standard stretcher car as a transporting method in the operating room	Device: Standard stretcher car
Wagon group	Active Comparator	Use a wagon as a transporting method in the operating room	Device: Wagon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wagon	Device		Wagon group	wagonTM, Step 2 company
Standard stretcher car

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale		From entry of operating room to induction of anesthesia

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologist physical status I
scheduled for elective surgery under general anesthesia

Exclusion Criteria:

history of anesthesia or surgery
developmental delay
weighing over than 38kg
severe pain
administrated psychotomimetic drug

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonnam National University Hospital		Gwangju		505-757	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D002652	Child Behavior

Ancestor Terms

ID	Term
D001523	Mental Disorders
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided