Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey

NCT03468608 | Unknown

• 1 other identifier: 1000056420
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction

Keywords

procedural sedation; paediatric; parental satisfaction

Outcome Measures

Primary Outcomes (1)

• Parental Satisfaction with Procedural Sedation

  determined via development/validation of a parental satisfaction tool

  immediately proceeding procedural sedation experience

Study Arms (4)

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.

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.

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.

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Parent population will be based on those receiving services within our central unit.

You may qualify if:

• child is receiving procedural sedation within the central unit at our facility
• child is aged 0-8 years

You may not qualify if:

• parent self-identifies as not being able to speak or read English
• work within the central unit providing procedural sedation at our facility
• none

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mark Crawford

  Anesthesiologist-in-Cheif

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist-in-Chief

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 16, 2018
• Study Start: September 26, 2017
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

CA (1)