Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery (SOULAGETAVIE)

September 14, 2010 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery-SOULAGETAVIE

The purpose of this project is to develop and evaluate the effects of a computer-tailored intervention targeting pain barriers and catastrophizing in adults having cardiac surgery.

The hypotheses are that in the experimental group, in comparison to the control group, participants will show lower levels of pain, less pain interference in their activities, less attitudinal barriers, and less pain catastrophizing.

A pilot-RCT is privileged to assess the preliminary effects of the intervention on the following outcomes: pain intensity, analgesic consumption, pain interference, barriers and pain catastrophizing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Hotel-Dieu (CHUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first intention cardiac surgery
  • 18 years old or more
  • able to fill up questionnaires in french

Exclusion Criteria:

  • participation to another psychosocial intervention
  • cognitive or psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain intensity
Time Frame: 24, 48, 72 hrs, 7 days, 6 months after surgery
24, 48, 72 hrs, 7 days, 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Canadian Institutes of Health Research (CIHR)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
GRISIIQ
FIIC
Chaire de recherche sur les nouvelles pratiques de soins infirmiers

Investigators

  • Study Director: José Côté, PhD, Centre de recherche du Centre Hospitalier de l'Universite de Montreal
  • Study Director: Manon Choinière, PhD, Centre de recherche du Centre Hospitalier de l'Universite de Montreal
  • Principal Investigator: Géraldine Martorella, PhD (c), Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

September 15, 2010

Last Update Submitted That Met QC Criteria

September 14, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE 09.214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe