Back to resultsIntervention Study to Enhance Patients' Pain Management After Cardiac Surgery
Primary Purpose
Pain, Pain, Postoperative, Other Functional Disturbances Following Cardiac Surgery
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pain Booklet
Sponsored by
About this trial
This is an interventional prevention trial for Pain
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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pain booklet
standard care
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity
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
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
analgesic intake
Quality of life
Full Information
NCT ID
NCT01976403
First Posted
November 28, 2011
Last Updated
November 21, 2014
Sponsor
Oslo Metropolitan University
Collaborators
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01976403
Brief Title
Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery
Official Title
AA Randomized Controlled Trial to Evaluate the Effect of an Intervention to Enhance Patients' Pain Management After Discharge From Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo Metropolitan University
Collaborators
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pain, Postoperative, Other Functional Disturbances Following Cardiac Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
416 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain booklet
Arm Type
Experimental
Arm Title
standard care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Pain Booklet
Intervention Description
The Pain Relief After Cardiac Surgery is originally a Canadian booklet. The booklet is further developed and modified for Norwegian patients
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360
Title
pain-related interference
Description
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
Time Frame
Baseline, day 7, day 30, day 90, day 180, day 360
Secondary Outcome Measure Information:
Title
analgesic intake
Time Frame
baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360
Title
Quality of life
Time Frame
baseline, day 7, day 90, day 180, day 360
Other Pre-specified Outcome Measures:
Title
Barriers to pain management
Time Frame
baseline
Title
pain sensitivity
Time Frame
baseline
Title
Hope
Time Frame
day 90, day 180, day 360
Title
Social support
Time Frame
day 90, day 180, day 360
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marit Leegaard, PhD RN
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
29291728
Citation
Bjornnes AK, Parry M, Lie I, Falk R, Leegaard M, Rustoen T. The association between hope, marital status, depression and persistent pain in men and women following cardiac surgery. BMC Womens Health. 2018 Jan 2;18(1):2. doi: 10.1186/s12905-017-0501-0.
Results Reference
derived
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Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery
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