A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
April 5, 2017 updated by: Yen-Ko Lin (980425), Kaohsiung Medical University Chung-Ho Memorial Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: control
No computed-assisted information program will be administered.
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|
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EXPERIMENTAL: intervention
computed-assisted information program will be administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
structured questionnaire
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
|
a structured questionnaire with knowledge measure and satisfaction will be delivered to the participants for data collection.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 7, 2009
Primary Completion (ACTUAL)
September 9, 2014
Study Completion (ACTUAL)
September 9, 2014
Study Registration Dates
First Submitted
April 15, 2013
First Submitted That Met QC Criteria
May 7, 2013
First Posted (ESTIMATE)
May 9, 2013
Study Record Updates
Last Update Posted (ACTUAL)
April 6, 2017
Last Update Submitted That Met QC Criteria
April 5, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUH-IRB- 980425
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.