Back to resultsEffect of Transportation Method on Preoperative Anxiety in Children
Primary Purpose
Anxiety, Child Behavior
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Wagon
Standard stretcher car
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
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
Sites / Locations
- Chonnam National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard stretcher group
Wagon group
Arm Description
Use a standard stretcher car as a transporting method in the operating room
Use a wagon as a transporting method in the operating room
Outcomes
Primary Outcome Measures
Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03018145
First Posted
January 10, 2017
Last Updated
December 29, 2017
Sponsor
Chonnam National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03018145
Brief Title
Effect of Transportation Method on Preoperative Anxiety in Children
Official Title
Effect of Transportation Method on Preoperative Anxiety in Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
March 25, 2017 (Actual)
Study Completion Date
April 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
4. Oversight
5. Study Description
Brief Summary
To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Child Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard stretcher group
Arm Type
Experimental
Arm Description
Use a standard stretcher car as a transporting method in the operating room
Arm Title
Wagon group
Arm Type
Active Comparator
Arm Description
Use a wagon as a transporting method in the operating room
Intervention Type
Device
Intervention Name(s)
Wagon
Other Intervention Name(s)
wagonTM, Step 2 company
Intervention Type
Device
Intervention Name(s)
Standard stretcher car
Other Intervention Name(s)
Stryker, Stryker medical
Primary Outcome Measure Information:
Title
Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale
Time Frame
From entry of operating room to induction of anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
505-757
Country
Korea, Republic of
12. IPD Sharing Statement
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Effect of Transportation Method on Preoperative Anxiety in Children
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