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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
GRISIIQ
FIIC
Chaire de recherche sur les nouvelles pratiques de soins infirmiers
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01084018
First received: March 8, 2010
Last updated: September 14, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Cardiac Surgery
Pain
Adult
Pain Management
 Behavioral: soulageTAVIE
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery-SOULAGETAVIE

Resource links provided by NLM:

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

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • pain intensity [ Time Frame: 24, 48, 72 hrs, 7 days, 6 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084018

Locations
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)
GRISIIQ
FIIC
Chaire de recherche sur les nouvelles pratiques de soins infirmiers
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
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

No publications provided by Centre hospitalier de l'Université de Montréal (CHUM)

Additional 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
Study First Received: March 8, 2010
Last Updated: September 14, 2010
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on June 17, 2013