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

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ClinicalTrials.gov Identifier: NCT01084018
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : September 15, 2010
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Pain Adult Pain Management Behavioral: soulageTAVIE Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery-SOULAGETAVIE
Study Start Date : February 2010
Primary Completion Date : June 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: soulageTAVIE
    VITaPaCS consists in a 30 minute-computer-tailored preoperative session, which is animated by a virtual nurse who guides the participant through a learning process about analgesic medication intake, pain communication, and cognitive restructuring. The information and the strategies provided are specifically tailored to the participants' profile, determined by a screening questionnaire, but also by their responses in real-time during the computer session. Two postoperative clinical reinforcements of ten minutes are also provided by the treating nurse based on the flags identified through the preoperative session.

Outcome Measures

Primary Outcome Measures :
  1. pain intensity [ Time Frame: 24, 48, 72 hrs, 7 days, 6 months after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084018

Canada, Quebec
Hotel-Dieu (CHUM)
Montreal, Quebec, Canada
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Canadian Institutes of Health Research (CIHR)
Chaire de recherche sur les nouvelles pratiques de soins infirmiers
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Study Director: José Côté, PhD Centre de recheche du CHUM (CRCHUM)
Study Director: Manon Choinière, PhD Centre de recheche du CHUM (CRCHUM)
Principal Investigator: Géraldine Martorella, PhD (c) Université de Montréal
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: José Côté, CRCHUM
ClinicalTrials.gov Identifier: NCT01084018     History of Changes
Other Study ID Numbers: CE 09.214
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
acute postoperative pain
nursing intervention