Pain, ChronicNCT05636345
An Evaluation of a Public Health Campaign in a High School Setting Targeting Pain Related Knowledge and Beliefs
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. 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
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Mar 2022to 17 Mar 2022
- 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
None listed.
Who cannot join
- Students not providing consent.
Trial locations and contacts
1 site in 1 country.
About this study
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. 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 beliefs about pain following a one-day pain education event.
Read the detailed description
The students will be asked to complete two questionnaires relating to their understanding of pain. One at the start of the conference and one at the end . The first questionnaire will gather demographic information (age, gender, ethnicity and any history of persistent pain). The following questions will be a series of multiple-choice questions relating to beliefs about persistent pain. The second questionnaire to be completed at the end of the day will be identical to the first, minus the demographic questions. Each questionnaire should take 5-10 minutes to complete. So total involvement in this study will be less than 20 minutes. The questionnaires will be provided in an unmarked brown envelope. The envelope will contain two questionnaires one marked "before" and one marked "after". Participants will be asked to complete the "before" questionnaire at the start of the day and then put it back in their envelope. At the end of the day, they will be asked to complete the "after questionnaire". Participants will keep the envelope with them during the day and at no point will their name or any other identifiable information go on the form. At the end of the day, they will be asked to leave the anonymous envelope in a designated area in the room.
- Conditions
- Pain, Chronic
- Being tested
- pain science education
- Keywords
- pain science education, pain knowledge, pain beliefs, experience of education
- 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
A full day of pain science education
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | High school students receiving a day of pain science education in multiple formats, lectures, experiential, completing a task which consolidates the information. Receives: Other: pain science education |
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: one day
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: one day
Vignette
Participants were asked what actions they would take if they had pain with regards to medication, scans, daily activity, exercise and work either based on yes/no answers or four to five multiple choice answers. The percentage of recommendations in keeping with guidelines were measured from 0-100% with lower scores indicating intended behaviours that were not in keeping with guidelines.
Measured: one day
Semi-structured interviews
To explore pain beliefs after the education day and experience of the education day.
Measured: 3 months after the pain education day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start17 Mar 2022
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- exploratory, single-site, mixed-methods study
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT05636345
- Sponsor's protocol ID
- teesside university
- Status last verified
- Jan 2023
- First submitted
- 23 Nov 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andias R, Sa-Couto P, Silva AG. Blended-Learning Pain Neuroscience Education and Exercise in High School Students With Chronic Neck Pain: A Randomized Controlled Trial. Phys Ther. 2022 Jun 3;102(6):pzac048. doi: 10.1093/ptj/pzac048.
PubMed 35485186Neto M, Andias R, Silva AG. Pain Neuroscience Education and Exercise for Neck Pain: A Focus Group Study on Adolescents' Views. Pediatr Phys Ther. 2018 Jul;30(3):196-201. doi: 10.1097/PEP.0000000000000511.
PubMed 29924066Pate JW, Noblet T, Hush JM, Hancock MJ, Sandells R, Pounder M, Pacey V. Exploring the concept of pain of Australian children with and without pain: qualitative study. BMJ Open. 2019 Oct 28;9(10):e033199. doi: 10.1136/bmjopen-2019-033199.
PubMed 31662406Pate JW, Simons LE, Rush G, Hancock MJ, Hush JM, Verhagen A, Pacey V. The Concept of Pain Inventory for Adults (COPI-Adult): Assessing Knowledge and Beliefs Regarding Pain Science Education. Clin J Pain. 2021 Oct 12;38(1):32-40. doi: 10.1097/AJP.0000000000000990.
PubMed 34636751Walsh DA, Radcliffe JC. Pain beliefs and perceived physical disability of patients with chronic low back pain. Pain. 2002 May;97(1-2):23-31. doi: 10.1016/s0304-3959(01)00426-2.
PubMed 12031776
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Public Health Campaign in a High School Setting Targeting Pain Related Knowledge and Beliefs
- ClinicalTrials.gov ID
- NCT05636345
- Acronym / sponsor ID
- teesside university
- Conditions
- Pain, Chronic
- Keywords
- pain science education, pain knowledge, pain beliefs, experience of education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 5 Dec 2022 (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. 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 beliefs about pain following a one-day pain education event.
Detailed description
The students will be asked to complete two questionnaires relating to their understanding of pain. One at the start of the conference and one at the end . The first questionnaire will gather demographic information (age, gender, ethnicity and any history of persistent pain). The following questions will be a series of multiple-choice questions relating to beliefs about persistent pain. The second questionnaire to be completed at the end of the day will be identical to the first, minus the demographic questions. Each questionnaire should take 5-10 minutes to complete. So total involvement in this study will be less than 20 minutes. The questionnaires will be provided in an unmarked brown envelope. The envelope will contain two questionnaires one marked "before" and one marked "after". Participants will be asked to complete the "before" questionnaire at the start of the day and then put it back in their envelope. At the end of the day, they will be asked to complete the "after questionnaire". Participants will keep the envelope with them during the day and at no point will their name or any other identifiable information go on the form. At the end of the day, they will be asked to leave the anonymous envelope in a designated area in the room.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- exploratory, single-site, mixed-methods study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: pain science educationHigh school students receiving a day of pain science education in multiple formats, lectures, experiential, completing a task which consolidates the information. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
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 educationA full day of pain science education | Other | Intervention group |
Primary outcome
Pain Beliefs Questionnaire (PBQ)
Time frame: one day
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.
Concept of Pain Inventory-Adult (COPI-Adult)
Time frame: one day
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).
Vignette
Time frame: one day
Participants were asked what actions they would take if they had pain with regards to medication, scans, daily activity, exercise and work either based on yes/no answers or four to five multiple choice answers. The percentage of recommendations in keeping with guidelines were measured from 0-100% with lower scores indicating intended behaviours that were not in keeping with guidelines.
Semi-structured interviews
Time frame: 3 months after the pain education day
To explore pain beliefs after the education day and experience of the education day.
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 12 Jan 2023.
- Background: PubMed 35485186Andias R, Sa-Couto P, Silva AG. Blended-Learning Pain Neuroscience Education and Exercise in High School Students With Chronic Neck Pain: A Randomized Controlled Trial. Phys Ther. 2022 Jun 3;102(6):pzac048. doi: 10.1093/ptj/pzac048.
- Background: PubMed 29924066Neto M, Andias R, Silva AG. Pain Neuroscience Education and Exercise for Neck Pain: A Focus Group Study on Adolescents' Views. Pediatr Phys Ther. 2018 Jul;30(3):196-201. doi: 10.1097/PEP.0000000000000511.
- Background: PubMed 31662406Pate JW, Noblet T, Hush JM, Hancock MJ, Sandells R, Pounder M, Pacey V. Exploring the concept of pain of Australian children with and without pain: qualitative study. BMJ Open. 2019 Oct 28;9(10):e033199. doi: 10.1136/bmjopen-2019-033199.
- Background: PubMed 34636751Pate JW, Simons LE, Rush G, Hancock MJ, Hush JM, Verhagen A, Pacey V. The Concept of Pain Inventory for Adults (COPI-Adult): Assessing Knowledge and Beliefs Regarding Pain Science Education. Clin J Pain. 2021 Oct 12;38(1):32-40. doi: 10.1097/AJP.0000000000000990.
- Background: PubMed 12031776Walsh DA, Radcliffe JC. Pain beliefs and perceived physical disability of patients with chronic low back pain. Pain. 2002 May;97(1-2):23-31. doi: 10.1016/s0304-3959(01)00426-2.
- Individual participant dataSharing planned: No
Related trials for Pain, Chronic
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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 0 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 12 Jan 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: one day). 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 NCT05636345, which also lists 5 linked publications.
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 12 Jan 2023.