Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment
1 other identifier
observational
1,079
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJuly 12, 2016
December 1, 2015
6 months
April 30, 2015
July 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)
Self 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).
Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected average of 1 hour
Study Arms (1)
Patients receiving standard procedures
Interventions
Eligibility Criteria
Terminally ill patients, cancer and non-cancer, admitted in a palliative care service (inpatients or outpatients), that are undergoing at least one procedure considered in the study, as a part of their Individual Care Plan (ICP).
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Antea Foundationlead
Study Sites (1)
San Marco hospice
Latina, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Casale, Medicine
Antea Foundation
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 8, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
July 12, 2016
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will not share