Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

Not Applicable

Completed

• Conditions: Pain, Postoperative; Pain; Other Functional Disturbances Following Cardiac Surgery
• Interventions: Behavioral: Pain Booklet

• Registration Number: NCT01976403
• Lead Sponsor: Oslo Metropolitan University

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:

1. Develop and implement a pain booklet to improve pain management after cardiac surgery

2. Evaluate the effect of the pain booklet compared to a group of patients given usual care

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-28
• Study Start: 2012-01
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-21
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pain booklet	Pain Booklet	-

Primary Outcome Measures

Name	Time	Method
Pain intensity	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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway