Postoperative PainNCT01595035
A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
A study testing psychoeducational in people with Postoperative Pain and Chronic Pain, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
Evidence indicates that postoperative pain after day surgery is inadequately controlled. Patients have different experiences and knowledge about how to deal with pain, and the need for information and clarification may vary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Chronic Pain
- What is being tested?
- psychoeducational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- May 2012to Feb 2021
- 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
- > 18 years of age;
- able, to read, write, and understand Norwegian;
- are scheduled for orthopedic (shoulder, bunnies), or breast reconstruction surgery and
- have a telephone line.
Who cannot join
- Staying overnight in hospital
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo and Akershus University College of Apllied Sciences
Oslo, N-0130
About this study
Official title: A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Evidence indicates that postoperative pain after day surgery is inadequately controlled. Patients have different experiences and knowledge about how to deal with pain, and the need for information and clarification may vary. The aim of this study is to enhance pain management by academic detailing (patients' current knowledge and motivations are the basis for information) and nurse coaching (frequent and individualized support). The study consists of 4 phases; (1) a pilot study about patients experience with pain after surgery by a structured telephone interview; (2) development of an intervention to improve pain management; (3) implement and evaluate the intervention; (4) evaluate the incidence of chronic pain after day surgery. Even if patients are prescribed sufficient doses of analgesics, pain relief is dependent on patients' adherence with the analgesic regimen. Psychological factors, such as catastrophizing may also contribute to patients' experience of postoperative pain. Strategies that may be more effective than general information concerning surgery and pain management is academic detailing and nurse coaching, and will be used as frame for the intervention.
Hypothesis:
Read more
Over the seven days after surgery patients in the intervention group report;
- higher adherence with the analgesic regimen,
- have less pain intensity and pain interference with function and
- lower severity of side effects compared to the control group.
- Conditions
- Postoperative Pain, Chronic Pain
- Being tested
- psychoeducational
- Keywords
- Day surgery, Orthopedic surgery, Breast reconstruction surgery
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationalBehavioural
Patients randomized to the intervention group will receive written information about pain and pain treatment in a booklet before surgery and contacted by telephone 24, 48, 72 hours and 7 days after surgery to be coached in pain management
| Study group | Role | What they receive |
|---|---|---|
| counselling | Experimental | Patients who receive the Pain booklet and support by telephone Receives: Behavioral: psychoeducational |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain intensity
Brief Pain Inventory
Measured: 1 week
Secondary outcomes (2)
The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.
Measured: 1,2,3,7 day after surgery
Pain occurence
Brief Pain Inventory
Measured: 3 and 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2020
- Study completionFeb 2021
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 Postoperative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Helse Stavanger HF
- Responsible party
- Sponsor
- Investigators
- Berit Valeberg, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595035
- Sponsor's protocol ID
- 2011/1984
- Status last verified
- Feb 2021
- First submitted
- 7 May 2012
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Valeberg BT, Dihle A, Smastuen MC, Endresen AO, Rustoen T. The effects of a psycho-educational intervention to improve pain management after day surgery: A randomised clinical trial. J Clin Nurs. 2021 Apr;30(7-8):1132-1143. doi: 10.1111/jocn.15659. Epub 2021 Jan 25.
PubMed 33432643
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
- ClinicalTrials.gov ID
- NCT01595035
- Acronym / sponsor ID
- 2011/1984
- Conditions
- Postoperative Pain, Chronic Pain
- Keywords
- Day surgery, Orthopedic surgery, Breast reconstruction surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Helse Stavanger HF
- Study start
- May 2012
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 9 May 2012 (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.
Evidence indicates that postoperative pain after day surgery is inadequately controlled. Patients have different experiences and knowledge about how to deal with pain, and the need for information and clarification may vary. The aim of this study is to enhance pain management by academic detailing (patients' current knowledge and motivations are the basis for information) and nurse coaching (frequent and individualized support). The study consists of 4 phases; (1) a pilot study about patients experience with pain after surgery by a structured telephone interview; (2) development of an intervention to improve pain management; (3) implement and evaluate the intervention; (4) evaluate the incidence of chronic pain after day surgery. Even if patients are prescribed sufficient doses of analgesics, pain relief is dependent on patients' adherence with the analgesic regimen. Psychological factors, such as catastrophizing may also contribute to patients' experience of postoperative pain. Strategies that may be more effective than general information concerning surgery and pain management is academic detailing and nurse coaching, and will be used as frame for the intervention.
Hypothesis:
Over the seven days after surgery patients in the intervention group report;
- higher adherence with the analgesic regimen,
- have less pain intensity and pain interference with function and
- lower severity of side effects compared to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| counselling | Experimental | Behavioral: psychoeducationalPatients who receive the Pain booklet and support by telephone |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years of age;
- able, to read, write, and understand Norwegian;
- are scheduled for orthopedic (shoulder, bunnies), or breast reconstruction surgery and
- have a telephone line.
Key exclusion criteria (1 listed)
- Staying overnight in hospital
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 |
|---|---|---|
| psychoeducationalPatients randomized to the intervention group will receive written information about pain and pain treatment in a booklet before surgery and contacted by telephone 24, 48, 72 hours and 7 days after surgery to be coached in pain management | Behavioural | counselling |
Primary outcome
Average pain intensity
Time frame: 1 week
Brief Pain Inventory
2 secondary outcomes
The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.
Time frame: 1,2,3,7 day after surgery
Pain occurence
Time frame: 3 and 6 month after surgery
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 2 Mar 2021.
- Derived from this study: PubMed 33432643Valeberg BT, Dihle A, Smastuen MC, Endresen AO, Rustoen T. The effects of a psycho-educational intervention to improve pain management after day surgery: A randomised clinical trial. J Clin Nurs. 2021 Apr;30(7-8):1132-1143. doi: 10.1111/jocn.15659. Epub 2021 Jan 25.
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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.
Berit Valeberg, PhD 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 psychoeducational in people with Postoperative Pain and Chronic Pain, 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 4 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 2 Mar 2021. 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?
Average pain intensity (time frame: 1 week). 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 NCT01595035, 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 2 Mar 2021.