Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

NCT ID: NCT01976403

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Pain Pain, Postoperative Other Functional Disturbances Following Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Pain booklet

Group Type EXPERIMENTAL

Pain Booklet

Intervention Type BEHAVIORAL

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

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pain Booklet

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Oslo Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Marit Leegaard

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marit Leegaard, PhD RN

Role: PRINCIPAL_INVESTIGATOR

Oslo Metropolitan University

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 29291728 (View on PubMed)

Other Identifiers

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2011/2010

Identifier Type: -

Identifier Source: org_study_id