CompletedNCT02437929Updated Jul 12, 2016

Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

An observational study in Breakthrough Pain, Pain Due to Certain Specified Procedures and Pain, sponsored by Antea Foundation. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-12.

Sponsored by Antea Foundation · Observational

Study type: Observational
Time perspective: Prospective
Enrollment: 1,079
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

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

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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).

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

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 design

Time perspective: Prospective
Enrollment: 1,079 participants (actual)
Patient registry: No

Groups and cohorts

Patients receiving standard procedures
Procedure: Mobilization · Procedure: Positioning · Procedure: Personal Hygiene Care · Procedure: Bladder catheterization · Procedure: Wound care · Procedure: Subcutaneous drugs administration

Interventions

ProcedureMobilization
ProcedurePositioning
ProcedurePersonal Hygiene Care
ProcedureBladder catheterization
ProcedureWound care
ProcedureSubcutaneous drugs administration

What researchers measure

Primary outcomes

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).
Time frame: 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 locations

1 site

San Marco hospice
Latina, Italy

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT02437929
Lead sponsor: Antea Foundation
Responsible party: Sponsor
First posted: May 8, 2015
Start date: Jun 2015
Primary completion: Dec 2015
Completion: Apr 2016
Last update: Jul 12, 2016

Study contacts

Giuseppe Casale, Medicine

principal investigator · Antea Foundation

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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