Back to resultsA Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
Primary Purpose
Informed Consent Process
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
computed-assisted information program
Sponsored by
About this trial
This is an interventional health services research trial for Informed Consent Process
Eligibility Criteria
Inclusion Criteria:
- Parents with patients under 18 years of age
- patients receive the procedural sedation and anesthesia in the emergency department
Exclusion Criteria:
- clinically unstable
- refuse to participate
- unable to understand the consent process for this study
Sites / Locations
- Kaohsiung Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
intervention
Arm Description
No computed-assisted information program will be administered.
computed-assisted information program will be administered.
Outcomes
Primary Outcome Measures
structured questionnaire
a structured questionnaire with knowledge measure and satisfaction will be delivered to the participants for data collection.
Secondary Outcome Measures
Full Information
NCT ID
NCT01850329
First Posted
April 15, 2013
Last Updated
April 5, 2017
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01850329
Brief Title
A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
Official Title
A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 7, 2009 (Actual)
Primary Completion Date
September 9, 2014 (Actual)
Study Completion Date
September 9, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ED) about risks, benefits, and alternatives to receiving procedural sedation for their children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Informed Consent Process
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
No computed-assisted information program will be administered.
Arm Title
intervention
Arm Type
Experimental
Arm Description
computed-assisted information program will be administered.
Intervention Type
Other
Intervention Name(s)
computed-assisted information program
Primary Outcome Measure Information:
Title
structured questionnaire
Description
a structured questionnaire with knowledge measure and satisfaction will be delivered to the participants for data collection.
Time Frame
before and immediately after the intervention when participants are in the emergency department, it is expected to take an expected average time of one hour
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parents with patients under 18 years of age
patients receive the procedural sedation and anesthesia in the emergency department
Exclusion Criteria:
clinically unstable
refuse to participate
unable to understand the consent process for this study
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
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