Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey

Satisfaction Clinical Trial

Official title:

Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03468608
• Other study ID #: 1000056420
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Satisfaction

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