Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

NCT01976403 | Completed

• 1 other identifier: 2011/2010
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

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

Conditions

Pain; Pain, Postoperative; Other Functional Disturbances Following Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• 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

Other Outcomes (4)

• Barriers to pain management

  baseline

• pain sensitivity

  baseline

• Hope

  day 90, day 180, day 360

Study Arms (2)

Pain booklet

EXPERIMENTAL

Behavioral: Pain Booklet

standard care

NO INTERVENTION

Interventions

Pain Booklet BEHAVIORAL

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

Pain booklet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 29291728 DERIVED

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Marit Leegaard, PhD RN

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: November 5, 2013
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

NO (1)