Knowledge, Attitudes, PracticeNCT03710837
The Effect of Pain Education on Multidisciplinary Healthcare Students' Understanding of Chronic Pain
A study testing Pain neuroscience education and Red flag education in people with Knowledge, Attitudes, Practice, run by Teesside University at 1 site in United Kingdom.
Trial summary
Chronic pain is the leading cause of disability worldwide affecting just under 28 million people in the UK. Chronic pain conditions require a biopsychosocial rather than a biomedical model of care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- Pain neuroscience education and Red flag education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 15 Oct 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pre-registration student at Teesside University in one of following six disciplines: paramedics, occupational therapists, physiotherapists, midwifery, nursing, diagnostic radiography.
Who cannot join
- Disciplines other than those listed above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pain Education on Multidisciplinary Healthcare Students' Understanding of Chronic Pain, Clinical Recommendations and Attitudes Towards People With Chronic Pain: a Mixed-methods Randomised Controlled Trial
Chronic pain is the leading cause of disability worldwide affecting just under 28 million people in the UK. Chronic pain conditions require a biopsychosocial rather than a biomedical model of care. Biomedical management lacks evidence of effectiveness but also has the potential to exacerbate the condition by raising fears and anxiety about potential pathological abnormalities.
Healthcare professionals often hold negative beliefs about people with chronic pain and view the condition within a biomedical framework. These negative attitudes can be observed at the pre-registration training stage of the health professionals' career. Thus, the pre-registration phase is an important point where an individual's understanding of, and beliefs about, pain and people with pain may be shaped for the future. The need for improved and better education of healthcare professionals to support best practice for low back pain with the aim of integrating professionals' management of low back pain and fostering innovation in practice is well recognised. This study seeks to quantify the benefits of pain education in knowledge, attitudes and beliefs. The findings may encourage other pre-registration institutions to deliver pain education in a more directed way and simultaneously support the International Association for the Study of Pain's (IASP) proposed integration pain education into existing curriculum.
Read the detailed description
In 2011 Briggs et al described pain education at undergraduate level for healthcare professionals as 'woefully inadequate'. Pain Neurophysiology Education (PNE) can improve undergraduates' pain understanding/management, however previous RCTs used single discipline groups and immediate follow-up. Investigation of the effectiveness of this education on students across the multi-professional team with medium-to-long-term follow-up will provide important new information on the generalisability of existing data and whether or not any changes in pain understanding/management are maintained over time.
This study aims to contribute to the development of neuromusculoskeletal physiotherapy by identifying whether or not this education, which aims to up skill healthcare professionals of the future, is effective and can change their behaviours in practice to enhance patient care in chronic pain management. PNE has been shown to be useful in patient care in conjunction with other treatment methods. If this intervention is successful in altering pain attitudes and knowledge in keeping with modern science then students may feel more confident and able to manage pain post qualification. The findings of this study will support or refute the addition of PNE into healthcare professional undergraduate programmes.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- Pain neuroscience education, Red flag education
- Keywords
- Education, Healthcare professional students
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
Also called Red flag education
Two different lectures covering essential clinical skills but one designed to explore the hypothesis
Red flag educationOther
Also called Pain neuroscience education
Two different lectures covering essential clinical skills but one designed to explore the hypothesis
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education | Experimental | Intervention: Pain neuroscience education group. One-off, 70 minute duration session delivered by Dr Cormac Ryan. Receives: Other: Pain neuroscience education |
| Red flag education | Experimental | Intervention: Red flags education group. One-off 70 minute duration session delivered by Dr Cormac Ryan. Receives: Other: Red flag education |
What is being measured
The primary outcome is the main question the study is designed to answer.
HC-PAIRS questionnaire
Health Care Providers Pain and Impairment Relationship Scale - assessing attitudes and beliefs towards pain using a 13 item validated questionnaire. High score is a worse outcome. Scores range from 13-91.
Measured: 6 months
Revised Neurophysiology Quiz
Measures knowledge of pain physiology using a 12 point validated questionnaire. Low score is poor sign. Scores range from 0-12.
Measured: 6 months
Case vignette
Measures clinical practise behaviours in pain management. A validated proxy measure of clinical behaviour, MCQ weighted as appropriate or inappropriate according to current national clinical guidelines. A low score is good, and scores range from 4 to 20.
Measured: 6 months
Red flag knowledge
Measures knowledge of red flags. Low score is a poor sign. Scores range from 0-10.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Oct 2018
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge, Attitudes, PracticeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi disciplinary randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mrs Jagjit Mankelow, Teesside University
- Investigators
- Denis Martin, PhD, Study director, Professor at Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710837
- Sponsor's protocol ID
- 095/18
- Status last verified
- Mar 2020
- First submitted
- 9 Oct 2018
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain Education on Multidisciplinary Healthcare Students' Understanding of Chronic Pain, Clinical Recommendations and Attitudes Towards People With Chronic Pain: a Mixed-methods Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03710837
- Acronym / sponsor ID
- 095/18
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- Education, Healthcare professional students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 18 Oct 2018 (actual)
- 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.
Chronic pain is the leading cause of disability worldwide affecting just under 28 million people in the UK. Chronic pain conditions require a biopsychosocial rather than a biomedical model of care. Biomedical management lacks evidence of effectiveness but also has the potential to exacerbate the condition by raising fears and anxiety about potential pathological abnormalities.
Healthcare professionals often hold negative beliefs about people with chronic pain and view the condition within a biomedical framework. These negative attitudes can be observed at the pre-registration training stage of the health professionals' career. Thus, the pre-registration phase is an important point where an individual's understanding of, and beliefs about, pain and people with pain may be shaped for the future. The need for improved and better education of healthcare professionals to support best practice for low back pain with the aim of integrating professionals' management of low back pain and fostering innovation in practice is well recognised. This study seeks to quantify the benefits of pain education in knowledge, attitudes and beliefs. The findings may encourage other pre-registration institutions to deliver pain education in a more directed way and simultaneously support the International Association for the Study of Pain's (IASP) proposed integration pain education into existing curriculum.
Detailed description
In 2011 Briggs et al described pain education at undergraduate level for healthcare professionals as 'woefully inadequate'. Pain Neurophysiology Education (PNE) can improve undergraduates' pain understanding/management, however previous RCTs used single discipline groups and immediate follow-up. Investigation of the effectiveness of this education on students across the multi-professional team with medium-to-long-term follow-up will provide important new information on the generalisability of existing data and whether or not any changes in pain understanding/management are maintained over time.
This study aims to contribute to the development of neuromusculoskeletal physiotherapy by identifying whether or not this education, which aims to up skill healthcare professionals of the future, is effective and can change their behaviours in practice to enhance patient care in chronic pain management. PNE has been shown to be useful in patient care in conjunction with other treatment methods. If this intervention is successful in altering pain attitudes and knowledge in keeping with modern science then students may feel more confident and able to manage pain post qualification. The findings of this study will support or refute the addition of PNE into healthcare professional undergraduate programmes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi disciplinary randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education | Experimental | Other: Pain neuroscience educationIntervention: Pain neuroscience education group. One-off, 70 minute duration session delivered by Dr Cormac Ryan. |
| Red flag education | Experimental | Other: Red flag educationIntervention: Red flags education group. One-off 70 minute duration session delivered by Dr Cormac Ryan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-registration student at Teesside University in one of following six disciplines: paramedics, occupational therapists, physiotherapists, midwifery, nursing, diagnostic radiography.
Key exclusion criteria (1 listed)
- Disciplines other than those listed above
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 neuroscience educationAlso: Red flag educationTwo different lectures covering essential clinical skills but one designed to explore the hypothesis | Other | Pain neuroscience education |
| Red flag educationAlso: Pain neuroscience educationTwo different lectures covering essential clinical skills but one designed to explore the hypothesis | Other | Red flag education |
Primary outcome
HC-PAIRS questionnaire
Time frame: 6 months
Health Care Providers Pain and Impairment Relationship Scale - assessing attitudes and beliefs towards pain using a 13 item validated questionnaire. High score is a worse outcome. Scores range from 13-91.
Revised Neurophysiology Quiz
Time frame: 6 months
Measures knowledge of pain physiology using a 12 point validated questionnaire. Low score is poor sign. Scores range from 0-12.
Case vignette
Time frame: 6 months
Measures clinical practise behaviours in pain management. A validated proxy measure of clinical behaviour, MCQ weighted as appropriate or inappropriate according to current national clinical guidelines. A low score is good, and scores range from 4 to 20.
Red flag knowledge
Time frame: 6 months
Measures knowledge of red flags. Low score is a poor sign. Scores range from 0-10.
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 23 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Denis Martin, PhD study director
Professor at Teesside 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 neuroscience education and Red flag education in people with Knowledge, Attitudes, Practice, run by Teesside University at 1 site in United Kingdom.
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 1 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 23 Mar 2020. 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 United Kingdom. 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?
HC-PAIRS questionnaire (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2020.