SatisfactionNCT03468608
Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey
An observational study of Satisfaction, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Satisfaction
- How many people
- 650 participants
- Where
- 1 siteCanada
- Study dates
- 26 Sep 2017to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Parent population will be based on those receiving services within our central unit.
Who may be able to join
- child is receiving procedural sedation within the central unit at our facility
- child is aged 0-8 years
- work within the central unit providing procedural sedation at our facility
Who cannot join
- parent self-identifies as not being able to speak or read English
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Satisfaction
- Keywords
- procedural sedation, paediatric, parental satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Satisfaction with Procedural Sedation
determined via development/validation of a parental satisfaction tool
Measured: immediately proceeding procedural sedation experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start26 Sep 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatisfactionStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Crawford, The Hospital for Sick Children
- Investigators
- Mark Crawford, Principal investigator, Anesthesiologist-in-Cheif
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468608
- Sponsor's protocol ID
- 1000056420
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2018
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey
- ClinicalTrials.gov ID
- NCT03468608
- Acronym / sponsor ID
- 1000056420
- Conditions
- Satisfaction
- Keywords
- procedural sedation, paediatric, parental satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Parent population will be based on those receiving services within our central unit.
Key inclusion criteria (3 listed)
- child is receiving procedural sedation within the central unit at our facility
- child is aged 0-8 years
- work within the central unit providing procedural sedation at our facility
Key exclusion criteria (2 listed)
- parent self-identifies as not being able to speak or read English
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parental Satisfaction with Procedural Sedation
Time frame: immediately proceeding procedural sedation experience
determined via development/validation of a parental satisfaction tool
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Crawford principal investigator
Anesthesiologist-in-Cheif
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Satisfaction with Procedural Sedation (time frame: immediately proceeding procedural sedation experience). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.