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Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03468608
Recruitment Status : Enrolling by invitation
First Posted : March 16, 2018
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Mark Crawford, The Hospital for Sick Children

Study Description
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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
Satisfaction

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
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Study Type : Observational
Estimated 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 : September 26, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022
Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Parental Satisfaction with Procedural Sedation [ Time Frame: immediately proceeding procedural sedation experience ]
    determined via development/validation of a parental satisfaction tool


Eligibility Criteria
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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parent population will be based on those receiving services within our central unit.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468608


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Mark Crawford Anesthesiologist-in-Cheif
More Information
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Responsible Party: Mark Crawford, Anesthesiologist-in-Chief, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03468608    
Other Study ID Numbers: 1000056420
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Crawford, The Hospital for Sick Children:
procedural sedation
paediatric
parental satisfaction