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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03468608
Other study ID # 1000056420
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 26, 2017
Est. completion date June 30, 2024

Study information

Verified date April 2023
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The quality of care associated with medical procedures, such as procedural sedation, has historically been assessed from the perspective of the healthcare professional, wherein the appropriateness of the services provided and the skill with which this care was performed were considered. However, more recently, the perspectives of consumers of healthcare services (i.e. the patients) have also been sought in the form of patient satisfaction. A review of the literature shows that patient satisfaction is routinely assessed when determining the effectiveness of sedation; however, it is less frequently assessed as the primary outcome. In child-specific, validated studies, limitations are noted with respect to being validated in a language other than English and failing to encompass a variety of procedures. As a result, these validated tools are not appropriate for use with pediatric populations undergoing procedural sedation in North America, nor are these validated tools amenable to comparison with our proposed tool.


Description:

Due to the central unit procedural sedation team servicing several areas of specialty, a varied patient satisfaction tool is required to ensure all concerns pertaining to sedation in each specialty are addressed, as well as allowing consistency between specialties to be examined. Therefore, the objective is to develop and validate a procedural sedation satisfaction tool for use with a variety of specialties requiring pediatric procedural sedation.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 650
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 8 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parental Satisfaction with Procedural Sedation determined via development/validation of a parental satisfaction tool immediately proceeding procedural sedation experience
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