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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

March 8, 2010
September 14, 2010
February 2010
June 2010   (final data collection date for primary outcome measure)
pain intensity [ Time Frame: 24, 48, 72 hrs, 7 days, 6 months after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01084018 on ClinicalTrials.gov Archive Site
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Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Cardiac Surgery
  • Pain
  • Adult
  • Pain Management
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.
Not Provided
Martorella G, Côté J, Racine M, Choinière M. Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial. J Med Internet Res. 2012 Dec 14;14(6):e177. doi: 10.2196/jmir.2070.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01084018
CE 09.214
Yes
José Côté, CRCHUM
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
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
Centre hospitalier de l'Université de Montréal (CHUM)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP