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Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02437929
Enrollment
1079
Registered
2015-05-08
Start date
2015-06-30
Completion date
2016-04-30
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breakthrough Pain, Pain Due to Certain Specified Procedures, Pain, Cancer, Terminal Disease

Brief summary

This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.

Interventions

PROCEDUREMobilization
PROCEDUREPositioning
PROCEDUREPersonal Hygiene Care
PROCEDUREWound care
PROCEDURESubcutaneous drugs administration

Sponsors

Antea Foundation
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients receiving the procedures included in this study as a part of their standard care * Patients that have expressed their consent to participate to the study by signing the informed consent document

Exclusion criteria

* Very serious or unstable clinical conditions with a Karnofsky Performance Status Index (KPS) \< 20 * Presence of neurological or psychiatric conditions, due to the original disease or concomitant diseases, interfering with the patient's level of consciousness or with judgment, such as to compromise compliance with the study protocol; * Not adequately controlled background pain (average NRS in the last 24 hours is \> 4) * Emergency procedures or procedures performed during night time (from 8 p.m. until 8 a.m)

Design outcomes

Primary

MeasureTime frameDescription
11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected average of 1 hourSelf reported pain intensity 10 minutes before the procedure, during the procedure (measured immediately after that the procedure is performed), 10 minutes after the procedure. Each item is scored 0-10 (0 = no pain; 10 = worst possible pain).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026