Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

NCT ID: NCT02437929

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1079 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving standard procedures

Mobilization

Intervention Type PROCEDURE

Positioning

Intervention Type PROCEDURE

Personal Hygiene Care

Intervention Type PROCEDURE

Bladder catheterization

Intervention Type PROCEDURE

Wound care

Intervention Type PROCEDURE

Subcutaneous drugs administration

Intervention Type PROCEDURE

Interventions

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Mobilization

Intervention Type PROCEDURE

Positioning

Intervention Type PROCEDURE

Personal Hygiene Care

Intervention Type PROCEDURE

Bladder catheterization

Intervention Type PROCEDURE

Wound care

Intervention Type PROCEDURE

Subcutaneous drugs administration

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antea Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Casale, Medicine

Role: PRINCIPAL_INVESTIGATOR

Antea Foundation

Locations

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San Marco hospice

Latina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PCPP02

Identifier Type: -

Identifier Source: org_study_id

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