NCT03018145

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

January 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2017

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
Last Updated

January 2, 2018

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

January 10, 2017

Last Update Submit

December 29, 2017

Conditions

AnxietyChild Behavior

Outcome Measures

Primary Outcomes (1)

  • Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale

    From entry of operating room to induction of anesthesia

Study Arms (2)

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

WagonDEVICE
Also known as: wagonTM, Step 2 company
Wagon group
Standard stretcher carDEVICE
Also known as: Stryker, Stryker medical
Standard stretcher group

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hospital

Gwangju, 505-757, South Korea

Location

MeSH Terms

Conditions

Anxiety DisordersChild Behavior

Interventions

Portable X-Ray

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiolgoy and Pain Medicine

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 11, 2017

Study Start

January 12, 2017

Primary Completion

March 25, 2017

Study Completion

April 20, 2017

Last Updated

January 2, 2018

Record last verified: 2017-11

Locations

KR(1)