Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

November 21, 2014 updated by: Marit Leegaard, Oslo Metropolitan University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care
Experimental: Pain booklet
Behavioral: Pain Booklet
The Pain Relief After Cardiac Surgery is originally a Canadian booklet. The booklet is further developed and modified for Norwegian patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, 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
Baseline, day 7, day 30, day 90, day 180, day 360

Secondary Outcome Measures

Outcome Measure
Time Frame
analgesic intake
Time Frame: baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360
baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360
Quality of life
Time Frame: baseline, day 7, day 90, day 180, day 360
baseline, day 7, day 90, day 180, day 360

Other Outcome Measures

Outcome Measure
Time Frame
Barriers to pain management
Time Frame: baseline
baseline
pain sensitivity
Time Frame: baseline
baseline
Hope
Time Frame: day 90, day 180, day 360
day 90, day 180, day 360
Social support
Time Frame: day 90, day 180, day 360
day 90, day 180, day 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo Metropolitan University

Collaborators

Oslo University Hospital

Investigators

  • Principal Investigator: Marit Leegaard, PhD RN, Oslo Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

October 29, 2013

First Posted (Estimate)

November 5, 2013

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 21, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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