Trials / Completed
CompletedNCT03956342
ClinRO Sedation Validation
Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 35 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study will conduct qualitative interviews to provide evidence for the content validity and comprehension of existing physician-reported measures of sedation levels of children receiving anesthesia to facilitate a diagnostic or surgical procedure. Information gained from this study will inform the use of the measure in studies that are part of the PTN.
Detailed description
The primary objective of this study is to assess the content validity and physician understanding of the Pediatric Sedation State Scale (PSSS) and the University of Michigan Sedation Scale (UMSS) via cognitive interviewing methods. Qualitative Interviewers will conduct 1 hour, phone-based cognitive interviews with clinicians to assess physicians' comprehension of items and response options on clinician reported pediatric sedation scales and clinician evaluation of the relevance of the scale to capture sedation levels.
Conditions
Timeline
- Start date
- 2019-04-15
- Primary completion
- 2019-11-15
- Completion
- 2019-11-15
- First posted
- 2019-05-20
- Last updated
- 2019-12-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03956342. Inclusion in this directory is not an endorsement.