Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976403
• Other study ID #: 2011/2010
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: November 21, 2014
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Oslo and Akershus University College of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Other Functional Disturbances Following Cardiac Surgery
• Pain
• Pain, Postoperative
• Pathologic Processes

Intervention

Behavioral:
• Pain Booklet
The Pain Relief After Cardiac Surgery is originally a Canadian booklet. The booklet is further developed and modified for Norwegian patients

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo and Akershus University College of Applied Sciences	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Barriers to pain management		baseline	No
Other	pain sensitivity		baseline	No
Other	Hope		day 90, day 180, day 360	No
Other	Social support		day 90, day 180, day 360	No
Primary	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	Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360	No
Primary	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	Baseline, day 7, day 30, day 90, day 180, day 360	No
Secondary	analgesic intake		baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360	No
Secondary	Quality of life		baseline, day 7, day 90, day 180, day 360	No