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

NCT01084018 | Completed Phase 1 DMC

• 1 other identifier: CE 09.214
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery; Pain; Adult; Pain Management

Keywords

acute postoperative pain; nursing intervention

Outcome Measures

Primary Outcomes (1)

• pain intensity

  24, 48, 72 hrs, 7 days, 6 months after surgery

Interventions

soulageTAVIE BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first intention cardiac surgery
• years old or more
• able to fill up questionnaires in french

You may not qualify if:

• participation to another psychosocial intervention
• cognitive or psychiatric disorder

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator
• GRISIIQ: collaborator
• FIIC: collaborator
• Chaire de recherche sur les nouvelles pratiques de soins infirmiers: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Hotel-Dieu (CHUM)

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 23241361 DERIVED

MeSH Terms

Conditions

Pain; Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes

Study Officials

• 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

  STUDY DIRECTOR

• Géraldine Martorella, PhD (c)

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 15, 2010

Record last verified: 2010-09

Locations

CA (1)