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A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yen-Ko Lin (980425), Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01850329
First received: April 15, 2013
Last updated: April 5, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Informed Consent Process
Other: computed-assisted information program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Health Services Research
Official Title: A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 67
Actual Study Start Date: December 7, 2009
Study Completion Date: September 9, 2014
Primary Completion Date: September 9, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
No computed-assisted information program will be administered.
Experimental: intervention
computed-assisted information program will be administered.
Other: computed-assisted information program

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850329

Locations
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
  More Information

Responsible Party: Yen-Ko Lin (980425), Attending physician, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01850329     History of Changes
Other Study ID Numbers: KMUH-IRB- 980425
Study First Received: April 15, 2013
Last Updated: April 5, 2017

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 28, 2017