Survey for Parental Perception of Procedural Analgosedati... | NCT06794879

Studies
Survey for Parental Perception of Procedural Analgosedation in Pediatric Age.

NCT06794879

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Jan 27, 2025Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Analgesia
Sensation, Hyperalgesic

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 11, 2024Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 21, 2025

First Submission Date that Met QC Criteria

Jan 21, 2025

First Posted Date

Jan 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2025

Last Update Posted Date

Jan 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The conduction of this study may provide useful information about how much parents know and understand about procedural sedation, helping to identify any gaps. In addition, expectations and concerns about procedural sedation may be highlighted so that strategies aimed at improving communication by health care personnel can be developed. The results may guide the development of training programs for health care personnel so as to improve the management of procedural sedation and interaction with parents.

Detailed Description

The study involves the completion of a survey by Parents/Guardians, the remaining interventions will be performed following the normal care procedure outpatient regimen, according to normal clinical practice.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify the parent's degree of agreement/disagreement with pediatric procedural analgosedation practices and factors that may influence it	The parent's degree of agreement/disagreement with pediatric procedural analgosedation practices and the factors that may influence it will be analyzed by administering a survey	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents of children between the ages of 2 months and 14 years who are afferent to the withdrawal clinic

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Parents of children between the ages of 2 months and 14 years who are afferent to the withdrawal clinic of the U.O. Urgent Pediatrician, Emergency Department and Short and Intensive Observation of IRCCS - Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laura Andreozzi, MD	Contact	0512143012		laura.andreozzi@aosp.bo.it

Overall Officials

Name	Affiliation	Role
Laura Andreozzi, MD	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Azienda Ospedaliero - Universitaria di Bologna	Recruiting	Bologna	Italy	40138	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia
D006930	Hyperalgesia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided