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

Pain Clinical Trial

— SOULAGETAVIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084018
• Other study ID #: CE 09.214
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 8, 2010
• Last updated: September 14, 2010
• Start date: February 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Adult
• Cardiac Surgery
• Pain
• Pain Management

Intervention

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.

Locations

Country	Name	City	State
Canada	Hotel-Dieu (CHUM)	Montreal	Quebec

Sponsors (6)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Canadian Institutes of Health Research (CIHR), Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Chaire de recherche sur les nouvelles pratiques de soins infirmiers, FIIC, GRISIIQ

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity		24, 48, 72 hrs, 7 days, 6 months after surgery	No