CClinicalTrials.gg
CompletedNCT01084018SOULAGETAVIEUpdated Sep 15, 2010

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

A Phase 1/2 interventional study of soulageTAVIE in Cardiac Surgery, Pain and Adult, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-15.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 1/2 and Interventional

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Surgery
  • Pain
  • Adult
  • Pain Management

Keywords

  • acute postoperative pain
  • nursing intervention
03

In context

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • participation to another psychosocial intervention
  • cognitive or psychiatric disorder
05

Study design

Phase
Phase 1 / Phase 2
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Interventions

  • BehavioralsoulageTAVIE

    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.

06

What researchers measure

Primary outcomes

  1. pain intensity

    Time frame: 24, 48, 72 hrs, 7 days, 6 months after surgery

07

Study locations

1 site
  • Hotel-Dieu (CHUM)
    Montreal, Quebec, Canada
08

References and documents

Publications

  • Martorella G, Cote J, Racine M, Choiniere 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. PubMed 23241361 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01084018
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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
First posted
Mar 10, 2010
Start date
Feb 2010
Primary completion
Jun 2010
Completion
Sep 2010
Last update
Sep 15, 2010

Study contacts

José Côté, PhD
study director · Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Manon Choinière, PhD
study director · Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Géraldine Martorella, PhD (c)
principal investigator · Université de Montréal

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion