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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02437929
Other study ID # PCPP02
Secondary ID
Status Completed
Phase N/A
First received April 30, 2015
Last updated July 11, 2016
Start date June 2015
Est. completion date April 2016

Study information

Verified date December 2015
Source Antea Associazione
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1079
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Mobilization

Positioning

Personal Hygiene Care

Bladder catheterization

Wound care

Subcutaneous drugs administration


Locations

Country Name City State
Italy San Marco hospice Latina

Sponsors (1)

Lead Sponsor Collaborator
Antea Associazione

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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