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

K

Kaohsiung Medical University

Status

Completed

Conditions

Informed Consent Process

Treatments

Other: computed-assisted information program

Study type

Interventional

Funder types

Other

Identifiers

NCT01850329
KMUH-IRB- 980425

Details and patient eligibility

About

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.

Enrollment

67 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

67 participants in 2 patient groups

control
No Intervention group
Description:
No computed-assisted information program will be administered.
intervention
Experimental group
Description:
computed-assisted information program will be administered.
Treatment:
Other: computed-assisted information program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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