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

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Overall Status: Completed
• CT.gov ID: NCT01084018
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other), GRISIIQ (Other), FIIC (Other), Chaire de recherche sur les nouvelles pratiques de soins infirmiers (Other), Centre de Recherche du Centre Hospitalier de l'Université de Montréal (Other)
• Enrollment: 60
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 8.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery; Pain; Adult; Pain Management	Behavioral: soulageTAVIE	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• 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: Feb 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Outcome Measures

Primary Outcome Measures

1. pain intensity [24, 48, 72 hrs, 7 days, 6 months after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• participation to another psychosocial intervention

• cognitive or psychiatric disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hotel-Dieu (CHUM)	Montreal	Quebec	Canada

Sponsors and Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)
• 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

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01084018
• Other Study ID Numbers: CE 09.214
• First Posted: Mar 10, 2010
• Last Update Posted: Sep 15, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: acute postoperative pain; nursing intervention

Study Results

No Results Posted as of Sep 15, 2010