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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Cancer; Breakthrough Pain; Pain Due to Certain Specified Procedures; Terminal Disease
• Intervention / Treatment: Procedure: Mobilization; Procedure: Positioning; Procedure: Personal Hygiene Care; Procedure: Bladder catheterization; Procedure: Wound care; Procedure: Subcutaneous drugs administration

• Study Type: Observational
• Enrollment (Actual): 1079

Contacts and Locations

Study Locations

• Italy
  • Latina, Italy
    • San Marco hospice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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)

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving standard procedures	Procedure: Mobilization; Procedure: Positioning; Procedure: Personal Hygiene Care; Procedure: Bladder catheterization; Procedure: Wound care; Procedure: Subcutaneous drugs administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Antea Foundation
• Investigators: Principal Investigator: Giuseppe Casale, Medicine, Antea Foundation

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Breakthrough Pain; Pain, Procedural
• Other Study ID Numbers: PCPP02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No