Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey

• Conditions: Satisfaction

• Registration Number: NCT03468608
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-09-26
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parental Satisfaction with Procedural Sedation	immediately proceeding procedural sedation experience	determined via development/validation of a parental satisfaction tool

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada