To set up a cohort of patients undergoing radiological interventions, which will serve as a platform for randomized evaluation of different pain and anxiety management strategies in order to improve on routine care by searching for a more effective…
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The pain is measured using a numeric rating scale (NRS) and anxiety using the
Richmond agiation-sedation scale (RASS) during the intervention, as part of
standard clinical practice.
Secondary outcome
Not applicable.
Background summary
In interventional radiology, minimally invasive treatment options are
increasing. However, these procedures can be painful or stressful to undergo.
Pain varies substantially from easily manageable with subcutaneous infiltration
to requiring full anesthesia. The unpredictable nature, in combination with the
logistical issues associated with moderate and deep sedation or full
anesthesia, leaves room for improved anesthetic care during interventional
radiology procedures.
Study objective
To set up a cohort of patients undergoing radiological interventions, which
will serve as a platform for randomized evaluation of different pain and
anxiety management strategies in order to improve on routine care by searching
for a more effective strategy for analgesia and/or anxiolysis from both patient
and physician standpoint.
Study design
Observational, prospective cohort study, according to the *cohort multiple
Randomised Controlled Trial* (cmRCT) design.
Study burden and risks
The burden of participation is minimal: Patient data will be collected from the
medical records.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must undergo a radiological procedure. As pain or anxiety is highly variable, there is no a priori limitation to particular procedures.
Exclusion criteria
- Less than 18 years of age;
- Not being capable of giving informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60591.041.17 |