ClinicalTrials.gg
Status unknownNCT03468608Updated Apr 5, 2023

Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey

An observational study in Satisfaction, sponsored by The Hospital for Sick Children. Status unknown at 1 site in Canada. Open to participants aged Up to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-05.

Sponsored by The Hospital for Sick Children · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
650
Ages
Up to 8 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Satisfaction

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Keywords

  • procedural sedation
  • paediatric
  • parental satisfaction
03

In context

Personal Satisfaction

541 studies on the registry are indexed under Personal Satisfaction; 93 are open to participants now.

This study's planned enrollment of 650 is above the median of 180 across 115 observational studies indexed under Personal Satisfaction.

Browse Personal Satisfaction studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 8 Years
Sexes eligible
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.

Eligibility 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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
650 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Parental Satisfaction with Procedural Sedation

    determined via development/validation of a parental satisfaction tool

    Time frame: immediately proceeding procedural sedation experience

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Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03468608
Responsible party
Mark Crawford (Anesthesiologist-in-Chief, The Hospital for Sick Children) — Principal investigator
First posted
Mar 16, 2018
Start date
Sep 26, 2017
Primary completion
Dec 31, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Apr 5, 2023

Study contacts

Mark Crawford
principal investigator · Anesthesiologist-in-Cheif

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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