NCT06794879

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 27, 2025

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

January 21, 2025

Last Update Submit

January 21, 2025

Conditions

AnalgesiaSensation, Hyperalgesic

Keywords

procedural analgosedation

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Italy, 40138, Italy

RECRUITING

MeSH Terms

Conditions

AgnosiaHyperalgesia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation Disorders

Study Officials

  • Laura Andreozzi, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Andreozzi, MD

CONTACT

0512143012laura.andreozzi@aosp.bo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 27, 2025

Study Start

December 11, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 27, 2025

Record last verified: 2024-12

Locations

IT(1)