Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01976403

Enrollment

416

Registered

2013-11-05

Start date

2012-01-31

Completion date

2014-09-30

Last updated

2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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. 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

Interventions

BEHAVIORALPain Booklet

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain intensity	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
pain-related interference	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

Measure	Time frame
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

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026