AnalgesiaProSed-24NCT06794879
Survey for Parental Perception of Procedural Analgosedation in Pediatric Age.
An observational study of Analgesia and Sensation, Hyperalgesic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Sensation, Hyperalgesic
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- 11 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- Parents of children between the ages of 2 months and 14 years who are afferent to the withdrawal clinic
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Italy, 40138
Laura Andreozzi, MD, 0512143012, laura.andreozzi@aosp.bo.it
Laura Andreozzi
About this study
Official title: Survey of Parental Perception of Procedural Analgosedation in Pediatric Age.
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.
Read the 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.
- Conditions
- Analgesia, Sensation, Hyperalgesic
- Keywords
- procedural analgosedation
- Medical subject headings
- Agnosia, Hyperalgesia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start11 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Andreozzi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794879
- Sponsor's protocol ID
- ProSed-24
- Acronym
- ProSed-24
- Status last verified
- Dec 2024
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- 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 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Parental Perception of Procedural Analgosedation in Pediatric Age.
- ClinicalTrials.gov ID
- NCT06794879
- Acronym / sponsor ID
- ProSed-24 / ProSed-24
- Conditions
- Analgesia, Sensation, Hyperalgesic
- Keywords
- procedural analgosedation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jan 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Parents of children between the ages of 2 months and 14 years who are afferent to the withdrawal clinic
Key exclusion criteria (1 listed)
- 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
Identify the parent's degree of agreement/disagreement with pediatric procedural analgosedation practices and factors that may influence it
Time frame: through study completion, an average of 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Related trials for Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
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.
Laura Andreozzi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Analgesia and Sensation, Hyperalgesic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Andreozzi, MD (0512143012, laura.andreozzi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the parent's degree of agreement/disagreement with pediatric procedural analgosedation practices and factors that may influence it (time frame: through study completion, an average of 1 year). 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 27 Jan 2025.