Chronic PainNCT04587596
An Exploration of the Impact of Pain Education on GP Practice Staff
An observational study of Chronic Pain, run by Teesside University at 1 site in United Kingdom.
Trial summary
The aim of the research project is to quantify GP practice staffs' knowledge of chronic pain, their attitudes towards people with chronic pain and their management of a hypothetical patient with chronic pain, following a pain education session. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain education
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 20 Dec 2019
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All non-NHS clinical staff at Linthorpe Surgery, principally nurses and doctors.
Who may be able to join
- Clinical non-NHS staff at a Middlesbrough GP Surgery.
Who cannot join
- Non-clinical staff at a Middlesbrough GP surgery and staff who are not directly employed by the Surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploration of the Impact of Pain Education on GP Practice Staff: a Mixed Methods Study
The aim of the research project is to quantify GP practice staffs' knowledge of chronic pain, their attitudes towards people with chronic pain and their management of a hypothetical patient with chronic pain, following a pain education session.
The study also seeks to explore GP practice staffs' experience of receiving the pain education, their understanding of pain following the education and if they perceive the education session has impacted upon their daily practice.
Read the detailed description
Inappropriate, biomedical based views of chronic pain are commonly held by health care professionals (HCPs) and these in turn can result in patients receiving sub-optimal care out of step with current guidelines. It has been found that healthcare professionals management techniques did not reflect recognised treatment guidelines and this was associated with their biomedical view of chronic pain.
Pain education/training sessions for health care staff may be an important step towards improving patient care for chronic pain. It has been found that there was improvement in nurses' knowledge after 2 different pain education sessions delivered to nurses however there was no long term follow up. Furthermore, no studies have targeted all members of staff at a GP surgery who will interact with the patient, and thus impact upon the care they receive.
Pain Neuroscience education (PNE) is an approach to pain education which uses pain science information to shift the belief system of the receiver away from a biomedical understanding of pain to a more biopsychosocial understanding of pain.
A number of studies have shown that this education can decrease biomedical attitudes in health care students. Thus, it may be that this education could produce similar positive effects in GP practice staff that could have positive implications for the care of patients with chronic pain.
Thus this study aims to assess the impact on attitudes and beliefs of pain education upon staff at a GP surgery in Middlesbrough. Attitudes and beliefs will be assessed before and after the delivery of education. In addition participants will be invited to attend one of two focus groups to further discuss their findings or thoughts about the lecture.
- Conditions
- Chronic Pain
- Being tested
- Pain education
- Keywords
- Chronic pain, Staff attitudes and beliefs, Education, GP surgery
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain educationOther
Also called Pain neurophysiology education, Therapeutic neurophysiology education
70 minute lecture about chronic pain and one focus group afterwards
| Study group | Role | What they receive |
|---|---|---|
| Clinical staff | All clinical staff employed at one surgery in Middlesbrough, UK who wish to participate Receives: Other: Pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
HC-PAIRS
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: 70 minutes
Revised pain neurophysiology quiz
Measures knowledge of pain physiology using a 12 point validated questionnaire. Low score is poor sign. Scores range from 0-12.
Measured: 70 minutes
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: 70 minutes
Interviews - qualitative assessment
Interviews to assess perception and intended application of lecture material
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Nov 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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 Chronic 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 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
- J Mankelow, MSc, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587596
- Sponsor's protocol ID
- 205/18
- Status last verified
- May 2021
- First submitted
- 7 Oct 2020
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mankelow J, Ryan CG, Green PW, Taylor PC, Martin D. An exploration of primary care healthcare professionals' understanding of pain and pain management following a brief pain science education. BMC Med Educ. 2022 Mar 28;22(1):211. doi: 10.1186/s12909-022-03265-2.
PubMed 35351106
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of the Impact of Pain Education on GP Practice Staff: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT04587596
- Acronym / sponsor ID
- 205/18
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Staff attitudes and beliefs, Education, GP surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 14 Oct 2020 (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.
The aim of the research project is to quantify GP practice staffs' knowledge of chronic pain, their attitudes towards people with chronic pain and their management of a hypothetical patient with chronic pain, following a pain education session.
The study also seeks to explore GP practice staffs' experience of receiving the pain education, their understanding of pain following the education and if they perceive the education session has impacted upon their daily practice.
Detailed description
Inappropriate, biomedical based views of chronic pain are commonly held by health care professionals (HCPs) and these in turn can result in patients receiving sub-optimal care out of step with current guidelines. It has been found that healthcare professionals management techniques did not reflect recognised treatment guidelines and this was associated with their biomedical view of chronic pain.
Pain education/training sessions for health care staff may be an important step towards improving patient care for chronic pain. It has been found that there was improvement in nurses' knowledge after 2 different pain education sessions delivered to nurses however there was no long term follow up. Furthermore, no studies have targeted all members of staff at a GP surgery who will interact with the patient, and thus impact upon the care they receive.
Pain Neuroscience education (PNE) is an approach to pain education which uses pain science information to shift the belief system of the receiver away from a biomedical understanding of pain to a more biopsychosocial understanding of pain.
A number of studies have shown that this education can decrease biomedical attitudes in health care students. Thus, it may be that this education could produce similar positive effects in GP practice staff that could have positive implications for the care of patients with chronic pain.
Thus this study aims to assess the impact on attitudes and beliefs of pain education upon staff at a GP surgery in Middlesbrough. Attitudes and beliefs will be assessed before and after the delivery of education. In addition participants will be invited to attend one of two focus groups to further discuss their findings or thoughts about the lecture.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical staff | – | Other: Pain educationAll clinical staff employed at one surgery in Middlesbrough, UK who wish to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All non-NHS clinical staff at Linthorpe Surgery, principally nurses and doctors.
Key inclusion criteria (1 listed)
- Clinical non-NHS staff at a Middlesbrough GP Surgery.
Key exclusion criteria (1 listed)
- Non-clinical staff at a Middlesbrough GP surgery and staff who are not directly employed by the 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 educationAlso: Pain neurophysiology education, Therapeutic neurophysiology education70 minute lecture about chronic pain and one focus group afterwards | Other | Clinical staff |
Primary outcome
HC-PAIRS
Time frame: 70 minutes
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 pain neurophysiology quiz
Time frame: 70 minutes
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: 70 minutes
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.
Interviews - qualitative assessment
Time frame: 1 hour
Interviews to assess perception and intended application of lecture material
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 7 May 2021.
- Derived from this study: PubMed 35351106Mankelow J, Ryan CG, Green PW, Taylor PC, Martin D. An exploration of primary care healthcare professionals' understanding of pain and pain management following a brief pain science education. BMC Med Educ. 2022 Mar 28;22(1):211. doi: 10.1186/s12909-022-03265-2.
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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.
J Mankelow, MSc principal investigator
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, 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 7 May 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 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 (time frame: 70 minutes). 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?
On the ClinicalTrials.gov record for NCT04587596, 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 7 May 2021.