AA Randomized Controlled Trial to Evaluate the Effect of an Intervention to Enhance Patients' Pain Management After Discharge From Cardiac Surgery

Oslo Metropolitan University1 site in 1 country416 target enrollmentJanuary 2012

ConditionsPain Pain, Postoperative Other Functional Disturbances Following Cardiac Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pain
Sponsor: Oslo Metropolitan University
Enrollment: 416
Locations: 1
Primary Endpoint: Pain intensity
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this randomized controlled trial is to evaluate the effect of an intervention formed as a pain booklet provided to patients at discharge from hospital following cardiac surgery.

The primary objectives are to:

Develop and implement a pain booklet to improve pain management after cardiac surgery
Evaluate the effect of the pain booklet compared to a group of patients given usual care

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oslo Metropolitan University

Responsible Party

Principal Investigator

Marit Leegaard

Associate Professor

Oslo Metropolitan University

Eligibility Criteria

Inclusion Criteria

•undergoing their first elective CABG, valve surgery or a combination
•receiving the standard preadmission information
•able to take care of themselves after discharge
•able to read and write Norwegian and fill in the questionnaires
•able to be contacted by telephone

Exclusion Criteria

•more than 12 hours at the intensive care unit after surgery

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360

Change from Baseline in pain intensity at day 1, day 2, day 3, day 4, day 7,day 30, day 90, day 180 and day 360

pain-related interference

Time Frame: Baseline, day 7, day 30, day 90, day 180, day 360

Change from Baseline in pain-related interference at day 1, day 2, day 3, day 4, day 7,day 30, day 90, day 180 and day 360

Secondary Outcomes

analgesic intake(baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360)
Quality of life(baseline, day 7, day 90, day 180, day 360)