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Completed

NCT Number: NCT01976403

Intervention Study to Enhance Patients' Pain Management After 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

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Key information

Conditions

Pain Neurologic Manifestations Other Functional Disturbances Following Cardiac Surgery Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain Booklet

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. analgesic intake

    Time frame: baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360

  2. Quality of life

    Time frame: baseline, day 7, day 90, day 180, day 360

Other outcomes

  1. Barriers to pain management

    Time frame: baseline

  2. pain sensitivity

    Time frame: baseline

  3. Hope

    Time frame: day 90, day 180, day 360

  4. Social support

    Time frame: day 90, day 180, day 360

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2013
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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