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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||September 2010|
- 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.
- pain intensity [ Time Frame: 24, 48, 72 hrs, 7 days, 6 months after surgery ]
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
|Montreal, Quebec, Canada|
|Study Director:||José Côté, PhD||Centre de Recherche du Centre Hospitalier de l'Université de Montréal|
|Study Director:||Manon Choinière, PhD||Centre de Recherche du Centre Hospitalier de l'Université de Montréal|
|Principal Investigator:||Géraldine Martorella, PhD (c)||Université de Montréal|