Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03468608
Collaborator
(none)
650
1
57.1
11.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    650 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey
    Actual Study Start Date :
    Sep 26, 2017
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Jun 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Parental Satisfaction with Procedural Sedation [immediately proceeding procedural sedation experience]

      determined via development/validation of a parental satisfaction tool

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

    Sponsors and Collaborators

    • The Hospital for Sick Children

    Investigators

    • Principal Investigator: Mark Crawford, Anesthesiologist-in-Cheif

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mark Crawford, Anesthesiologist-in-Chief, The Hospital for Sick Children
    ClinicalTrials.gov Identifier:
    NCT03468608
    Other Study ID Numbers:
    • 1000056420
    First Posted:
    Mar 16, 2018
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mark Crawford, Anesthesiologist-in-Chief, The Hospital for Sick Children

    Study Results

    No Results Posted as of Dec 17, 2021