Informed Consent Process Clinical Trial
Official title:
A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
| Verified date | April 2017 |
| Source | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 67 |
| Est. completion date | September 9, 2014 |
| Est. primary completion date | September 9, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Kaohsiung Medical University Hospital | Kaohsiung |
| Lead Sponsor | Collaborator |
|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | structured questionnaire | 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 |