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

NCT ID: NCT01084018

Last Updated: 2010-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Surgery Pain Adult Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

GRISIIQ

UNKNOWN

Sponsor Role collaborator

FIIC

UNKNOWN

Sponsor Role collaborator

Chaire de recherche sur les nouvelles pratiques de soins infirmiers

UNKNOWN

Sponsor Role collaborator

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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CRCHUM

Principal Investigators

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José Côté, PhD

Role: STUDY_DIRECTOR

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Manon Choinière, PhD

Role: STUDY_DIRECTOR

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Géraldine Martorella, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

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Hotel-Dieu (CHUM)

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 23241361 (View on PubMed)

Other Identifiers

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CE 09.214

Identifier Type: -

Identifier Source: org_study_id