PainNCT01976403
Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery
A study testing Pain Booklet in people with Pain and Pain, Postoperative, run by Oslo Metropolitan University at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pain, Postoperative, Other Functional Disturbances Following Cardiac Surgery
- What is being tested?
- Pain Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- more than 12 hours at the intensive care unit after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AA Randomized Controlled Trial to Evaluate the Effect of an Intervention to Enhance Patients' Pain Management After Discharge From 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:
- Develop and implement a pain booklet to improve pain management after cardiac surgery
- Evaluate the effect of the pain booklet compared to a group of patients given usual care
- Being tested
- Pain Booklet
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain BookletBehavioural
The Pain Relief After Cardiac Surgery is originally a Canadian booklet. The booklet is further developed and modified for Norwegian patients
| Study group | Role | What they receive |
|---|---|---|
| Pain booklet | Experimental | Not described Receives: Behavioral: Pain Booklet |
| standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, day 7, day 30, day 90, day 180, day 360
Secondary outcomes (2)
analgesic intake
Measured: baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360
Quality of life
Measured: baseline, day 7, day 90, day 180, day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Marit Leegaard, Oslo Metropolitan University
- Investigators
- Marit Leegaard, PhD RN, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976403
- Sponsor's protocol ID
- 2011/2010
- Status last verified
- Nov 2014
- First submitted
- 28 Nov 2011
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29291728
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AA Randomized Controlled Trial to Evaluate the Effect of an Intervention to Enhance Patients' Pain Management After Discharge From Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01976403
- Acronym / sponsor ID
- 2011/2010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Develop and implement a pain booklet to improve pain management after cardiac surgery
- Evaluate the effect of the pain booklet compared to a group of patients given usual care
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain booklet | Experimental | Behavioral: Pain Booklet |
| standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- more than 12 hours at the intensive care unit after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain BookletThe Pain Relief After Cardiac Surgery is originally a Canadian booklet. The booklet is further developed and modified for Norwegian patients | Behavioural | Pain booklet |
Primary outcome
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
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
2 secondary outcomes
analgesic intake
Time frame: baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360
Quality of life
Time frame: baseline, day 7, day 90, day 180, day 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 29291728Bjornnes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marit Leegaard, PhD RN principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Booklet in people with Pain and Pain, Postoperative, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01976403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.