Pain, ChronicNCT05722587
Students' Understanding and Beliefs About Pain Before and After a One-day Pain Science Education Conference: an Intervention
A study testing Pain science education in people with Pain, Chronic, run by Teesside University at 1 site in United Kingdom.
Trial summary
The beliefs held by students lead to behaviours in response to their pain which can be both helpful or a hindrance to how they manage their pain. The one-day education event aims to educate the cohort on the contemporary scientific understanding of persistent pain using a mixture of methods. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Pain science education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2023to 2 Jun 2023
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students at two specified schools in North Yorkshire who had been offered the pain study day in year 12 or are in the intervention or control school in year 12 or 13
- Aged above 16.
- Providing consent to participate.
Who cannot join
- Students not providing consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Students' Understanding and Beliefs About Pain Before and After a One-day Pain Science Education Conference: a Mixed-methods Evaluation
The beliefs held by students lead to behaviours in response to their pain which can be both helpful or a hindrance to how they manage their pain. The one-day education event aims to educate the cohort on the contemporary scientific understanding of persistent pain using a mixture of methods. It is hoped this event will result in an improvement in the alignment of beliefs and behaviours to contemporary understanding of persistent pain.
The principal aim is to evaluate the pre-post knowledge and beliefs about pain following a one-day pain education event in year 12 students, aged 16 or above.
Read the detailed description
The students will be asked to complete questionnaires three times relating to their understanding and beliefs relating and intended behaviour in the presence of pain. Once at the start of the conference and once at the end, then finally after 3 months. The questionnaire will gather demographic information (age, gender, ethnicity and any history of persistent pain). There will also be a series of multiple-choice questions relating to knowledge and beliefs about persistent pain. The three time points of questionnaire completion will see the students complete the same questionnaire except they will not have to repeat demographic questions. The questionnaire should take 5-10 minutes to complete each time. The questionnaires will be provided online and links will be provided to participants.
This is a non-randomised controlled trial and a second school selected as it is part of the same group of schools and equally matched according to the English Indices of Deprivation 2019. This school will complete the survey at the same time points.
- Conditions
- Pain, Chronic
- Being tested
- Pain science education
- Keywords
- pain knowledge, pain beliefs, pain behaviour, experience of intervention
- 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 science educationOther
Also called Pain neuroscience education
High school students receiving a day of pain science education in multiple formats, lectures, experiential, completing a task which consolidates the information.
| Study group | Role | What they receive |
|---|---|---|
| Pain education day | Experimental | Pain education day, lecture and experiential Receives: Other: Pain science education |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Beliefs Questionnaire (PBQ)
Helps to identify if participant beliefs are biomedical or biopsychosocial focussed, 12-item (Edwards et al, 1992, Walsh and Radcliffe, 2002). There are 2 scales within the PBQ: the organic beliefs scale has 8 items, with score ranges from 8-48, lower scores indicate less biomedical views and higher scores indicate more biomedical views. The psychological scale within the PBQ has 4 items with a score range of 4-24, a higher score indicates more biopsychosocial beliefs about pain and a lower score indicates less biopsychosocial beliefs.
Measured: 3 months
Secondary outcomes (1)
Concept of Pain Inventory-Adult (COPI-Adult)
The Concept of Pain Inventory-Adult was designed for assessing knowledge and beliefs about pain science (Pate et al, 2022). It is a 13-item questionnaire. Higher COPI-Adult scores reflect greater alignment with contemporary pain science (Total scores can range from 0-52).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start2 Mar 2023
- Primary completion2 Mar 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- multi site, non-randomised controlled, mixed methods study
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mrs Jagjit Mankelow, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722587
- Sponsor's protocol ID
- 2022 Oct 11360 Mankelow
- Status last verified
- Jul 2023
- First submitted
- 1 Feb 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Students' Understanding and Beliefs About Pain Before and After a One-day Pain Science Education Conference: a Mixed-methods Evaluation
- ClinicalTrials.gov ID
- NCT05722587
- Acronym / sponsor ID
- 2022 Oct 11360 Mankelow
- Conditions
- Pain, Chronic
- Keywords
- pain knowledge, pain beliefs, pain behaviour, experience of intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 10 Feb 2023 (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 beliefs held by students lead to behaviours in response to their pain which can be both helpful or a hindrance to how they manage their pain. The one-day education event aims to educate the cohort on the contemporary scientific understanding of persistent pain using a mixture of methods. It is hoped this event will result in an improvement in the alignment of beliefs and behaviours to contemporary understanding of persistent pain.
The principal aim is to evaluate the pre-post knowledge and beliefs about pain following a one-day pain education event in year 12 students, aged 16 or above.
Detailed description
The students will be asked to complete questionnaires three times relating to their understanding and beliefs relating and intended behaviour in the presence of pain. Once at the start of the conference and once at the end, then finally after 3 months. The questionnaire will gather demographic information (age, gender, ethnicity and any history of persistent pain). There will also be a series of multiple-choice questions relating to knowledge and beliefs about persistent pain. The three time points of questionnaire completion will see the students complete the same questionnaire except they will not have to repeat demographic questions. The questionnaire should take 5-10 minutes to complete each time. The questionnaires will be provided online and links will be provided to participants.
This is a non-randomised controlled trial and a second school selected as it is part of the same group of schools and equally matched according to the English Indices of Deprivation 2019. This school will complete the survey at the same time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multi site, non-randomised controlled, mixed methods study
| Arm | Type | Receives |
|---|---|---|
| Pain education day | Experimental | Other: Pain science educationPain education day, lecture and experiential |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Students at two specified schools in North Yorkshire who had been offered the pain study day in year 12 or are in the intervention or control school in year 12 or 13
- Aged above 16.
- Providing consent to participate.
Key exclusion criteria (1 listed)
- Students not providing consent.
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 science educationAlso: Pain neuroscience educationHigh school students receiving a day of pain science education in multiple formats, lectures, experiential, completing a task which consolidates the information. | Other | Pain education day |
Primary outcome
Pain Beliefs Questionnaire (PBQ)
Time frame: 3 months
Helps to identify if participant beliefs are biomedical or biopsychosocial focussed, 12-item (Edwards et al, 1992, Walsh and Radcliffe, 2002). There are 2 scales within the PBQ: the organic beliefs scale has 8 items, with score ranges from 8-48, lower scores indicate less biomedical views and higher scores indicate more biomedical views. The psychological scale within the PBQ has 4 items with a score range of 4-24, a higher score indicates more biopsychosocial beliefs about pain and a lower score indicates less biopsychosocial beliefs.
1 secondary outcome
Concept of Pain Inventory-Adult (COPI-Adult)
Time frame: 3 months
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 20 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 science education in people with Pain, Chronic, 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 3 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 20 Jul 2023. 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?
Pain Beliefs Questionnaire (PBQ) (time frame: 3 months). 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 20 Jul 2023.