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OpenTrials
Completed

NCT Number: NCT02437929

Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

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.

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Key information

Conditions

Breakthrough Pain Cancer Neoplasms Neurologic Manifestations Pain Pain Due to Certain Specified Procedures Pathological Conditions, Signs and Symptoms Signs and Symptoms Terminal Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Marco hospice

Latina, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mobilization

Procedure

Positioning

Procedure

Personal Hygiene Care

Procedure

Bladder catheterization

Procedure

Wound care

Procedure

Subcutaneous drugs administration

Procedure

Primary outcomes

  1. 11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)

    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

    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).

Sponsors and collaborators

Lead sponsor

Antea Foundation

Other

Registry information

Official study title

Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 8, 2015
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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