- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03468608
Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for Parents:
- child is receiving procedural sedation within the central unit at our facility
- child is aged 0-8 years
Exclusion Criteria for Parents:
- parent self-identifies as not being able to speak or read English
Inclusion Criteria for Healthcare Team Members:
- work within the central unit providing procedural sedation at our facility
Exclusion Criteria for Healthcare Team Members:
- none
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Phase 1: Instrument Development
An initial set of questionnaire items will be created based on the questionnaires noted in the literature review as well as the semi-structured interviews conducted with parents and healthcare team members in our facility.
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Phase 2: Pre-Test Evaluation
Parents and healthcare team members will be asked to comment on the quality of the draft questionnaire created in phase 1 of this study.
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Phase 3: Pilot
Parents will be asked to complete the questionnaire developed during phase 2 of this study. Upon completing the questionnaire, parents will be asked to rate the overall face validity of the tool using a 5-point Likert scale. Healthcare team members will be asked to rate the content validity of each item on the questionnaire. |
Phase 4: Validation
Parents will be asked to complete the questionnaire developed during phase 3 of this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental Satisfaction with Procedural Sedation
Time Frame: immediately proceeding procedural sedation experience
|
determined via development/validation of a parental satisfaction tool
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immediately proceeding procedural sedation experience
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Crawford, Anesthesiologist-in-Cheif
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1000056420
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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