Persistent Lower Back PainNCT06094517
What Are Persistent Lower Back Pain Patients' Views of Sleep Health Within an Outpatient Musculoskeletal Physiotherapy Setting?
An observational study of Persistent Lower Back Pain and Sleep Disturbance, run by Sheffield Hallam University.
Trial summary
The goal of this qualitative is to understand the views and opinions of patients with persistent lower back pain patients who are awaiting physiotherapy treatment with regards sleep their sleep health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Lower Back Pain, Sleep Disturbance, Lower Back Pain
- What is being tested?
- Interview
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 17 Apr 2024
- 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: Participants will be identified from self-referrals and General Practitioner (GP) referrals to outpatient Musculoskeletal Physiotherapy at Chesterfield Royal Hospital NHS Foundation Trust, Meeting the Inclusion / exclusion criteria.
Who may be able to join
- On waiting list for Outpatient MSK Physiotherapy at Chesterfield Royal Hospital NHS Foundation Trust
- PLBP (present ≥ 3 months)
- Patients ≥ 18 years
Who cannot join
- Not fluent in English
- Failure to understand study
- Previous spinal surgery
- Serous spinal pathology such as fractures or metastasis
- Inflammatory Arthritis
- Referral of pain below buttock
- Acute mental health episode
Trial locations and contacts
No sites are listed yet.
About this study
Official title: What Are Persistent Lower Back Pain Patients' Views of Sleep Health Within an Outpatient
The goal of this qualitative is to understand the views and opinions of patients with persistent lower back pain patients who are awaiting physiotherapy treatment with regards sleep their sleep health. The main questions it aims to answer are:
- Identify whether Patients with persistent lower back pain awaiting physiotherapy consider sleep health relevant to their condition.
- Understand whether persistent lower back pain patients awaiting physiotherapy consider sleep health within the remit of Physiotherapy?
- Understand how persistent lower back pain patients may want sleep health to be assessed or managed within an outpatient musculoskeletal Physiotherapy Setting?
Participants will undertake one semi structured interview and complete two secondary outcome measures: Pittsburgh Sleep Quality Index and Pain, Enjoyment of Life and General Activity Scale. Data will be analysed via Thematic Analysis.
Read the detailed description
Background:Approximately one third of western populations suffer from sleep disturbance at least once a week and with 6-10% meeting the threshold of insomnia (National Institute of Clinical Excellence, 2022). The estimated population of the United Kingdom (UK) affected by insomnia is 37% (Morphy et al., 2007). Diminished sleep is associated with increased pain perceptions, reduced pain thresholds, physical activity levels, immune function, cognition and quality of life. Moreover, a lack of sleep correlates with increased prevalence of diabetes, obesity, cardiovascular disease, depression, and mortality (Medi, Wille \& Hemels, 2017).
Over 90% of patients with Persistent Lower Back Pain (PLBP) receiving physiotherapy are affected by sleep disturbance (Roseen et al., 2020).Conventional Physiotherapy rehabilitation has shown effective in improving sleep quality in patients with PLBP as measured via Pittsburgh Sleep Quality Index (PSQI). However, Eadie et al. (2013) \& Roseen et al., (2020). There is a paucity of research exploring Physiotherapies role within sleep health. Equally, studies specific to Physiotherapies role are mainly reviewed from the clinician's perspective, with a scarceness of studies providing insight into the patient perspective. To date, no studies have canvassed the opinion of patients in Physiotherapy care on the profession's role in sleep health, creating a strong footing for the proposed investigation Physiotherapist place a high value on the importance of sleep health but struggle to provide inventions citing a lack of training, resource and time. The evidence based is heavily survey based and of a quantitative nature, lacking explanation of why barriers exist, warranting further qualitative investigation (Caudwell et al. 2020 and Siengsukon, Nelson \& Turkowitch 2023)
It is unclear how PLBP patients with sleep disturbance want to utilize their time in Physiotherapy care and their perceptions of Physiotherapies role within the management of sleep health (Siengsukon, Nelson \& Turkowitch 2023). The proposed study would be the first to be conducted in the UK, examining PLBP patients' expectations of sleep health management within outpatient MSK physiotherapy setting.
Design and Methods:Qualitative in nature, via individual semi-structured interviews, will allow the study to explore participants' feelings and beliefs (De Jonckheere \& Vaughn, 2019). The study topic is novel in design and will allow the capture of rich data and themes (Lincoln \& Guba, 1985), current evidence base lacks qualitative data, especially from a patient perspective(Caudwell et al. 2020).
Recruitment and Sample Size: Recruitment will occur until the point of data saturation is reached and new themes have stopped emerging. Dickerson, Klingman \& Jungquist (2016) comparable study found that interviewing 29 participants on the "Common meanings of good and bad sleep" met saturation point. Given their much wider focus, it is anticipated that interviewing 8-12 participants would meet data saturation in the proposed study. This will be reviewed for adequacy concurrently with data collection (De Jonckheere \& Vaughn 2019 and Malterud, Siersma \& Guassora, 2016).
Data-Collection: Semi-structured interviews will be directed by the interview guide. Transcriptions will then be reviewed and corresponded to interview notes taken to ensure accuracy. Further secondary outcome measures PSQI and Pain, Enjoyment of Life and General Activity Scale, will be collected prior to interviews via Google Forms Surveys.
Data Analysis: Data analysis will be completed by the principal investigator via a Reflexive Thematic Analysis approach.
- Dataset Familiarisation
- Data Coding
- Initial Theme Generation
- Theme Development and Review
- Theme Refining
- Writing Up
Reflexive Thematic Analysis provides a structured systematic process for the recognition of themes. It recognises the background of the research and celebrates their insight into the topic, allowing for meaningful generation of themes. Although themes should occur multiple times within the data, this approach allows for the relevance and quality of the data provided to best answer the research question as opposed to prevalence alone. To ensure rigour, prior to completing the trial practice interview with Senior Physiotherapist interested in sleep health and reviewed for appropriateness. During the interview and coding processes, a reflective log will be kept by the principal researcher, appraising their performance within the data collection and considering personal bias (Campbell et al., 2021). To ensure consistency, the interviews, initial coding and theme generation will be conducted by the Principal Investigator. Appropriateness will be reviewed by the First Supervisor.
- Being tested
- Interview
- Keywords
- Physiotherapy, Persistent Lower Back Pain, Sleep Disturbance, Lower Back Pain, Chronic Low-back Pain
- Medical subject headings
- Parasomnias, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Persistent Lower Back Pain Patients on waiting list under going a usual care pathway following referral to Physiotherapy will be interviewed for views on sleep health
| Study group | Role | What they receive |
|---|---|---|
| Observed Group | Patients with persistent lower back pain awaiting Physiotherapy care, undergoing interviews to assess their views of sleep health within and musculoskeletal outpatient Physiotherapy setting. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thematic Analysis
Thematic Analysis of Data from semi structured interview
Measured: Completed one within 2 week of recruitment to trial
Secondary outcomes (2)
Pittsburgh Sleep Quality Index
Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
Measured: Completed one within 2 week of recruitment to trial
Pain, Enjoyment of Life and General Activity Scale (PEG Scale)
Self-rated questionnaire which assesses Pain, Enjoyment of Life and General Activity via 3 separate visual analogue scales.
Measured: Completed one within 2 week of recruitment to trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion17 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Persistent Lower Back 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Chesterfield Royal Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094517
- Sponsor's protocol ID
- PLBP paitent view sleep Phyiso
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requests for anonymised core data will be considered upon request by the Principle Investigator Clive Smith ( via emails clivesmith1@nhs.net). Personal details will not be shared other than with responsible parties from Sheffield Hallam University or Chesterfield Royal Hospital NHS Foundation Trust in the case of concern safety concerns.
Publications
National Institute of Clinical Excellence. (2022). Insomnia. CKS. https://cks.nice.org.uk/topics/insomnia/background-information/prevalence
Morphy H, Dunn KM, Lewis M, Boardman HF, Croft PR. Epidemiology of insomnia: a longitudinal study in a UK population. Sleep. 2007 Mar;30(3):274-80.
PubMed 17425223Medic G, Wille M, Hemels ME. Short- and long-term health consequences of sleep disruption. Nat Sci Sleep. 2017 May 19;9:151-161. doi: 10.2147/NSS.S134864. eCollection 2017.
PubMed 28579842Roseen EJ, Gerlovin H, Femia A, Cho J, Bertisch S, Redline S, Sherman KJ, Saper R. Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):167-176. doi: 10.1007/s11606-019-05329-4. Epub 2019 Oct 30.
PubMed 31667747Eadie J, van de Water AT, Lonsdale C, Tully MA, van Mechelen W, Boreham CA, Daly L, McDonough SM, Hurley DA. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial. Arch Phys Med Rehabil. 2013 Nov;94(11):2083-92. doi: 10.1016/j.apmr.2013.04.017. Epub 2013 May 2.
PubMed 23643716Lincoln, Y. S., & Guba, E. G. (1985). Naturalistic inquiry. Sage
Caudwell, L., Himani, H., Khaw, A., Taylor, R., White, J., Rhodes, S., & Skinner, M. (2020). Attitudes and perceptions of health professionals towards sleep health: A systematic review. Physical Therapy Reviews, 25(5-6), 361-380.
Siengsukon CF, Nelson E, Turkowitch D. Barriers and Facilitators to Implementing Sleep Health into Outpatient Physical Therapist Practice: A Survey Study. J Allied Health. 2023 Summer;52(2):e55-e61.
PubMed 37269038DeJonckheere M, Vaughn LM. Semistructured interviewing in primary care research: a balance of relationship and rigour. Fam Med Community Health. 2019 Mar 8;7(2):e000057. doi: 10.1136/fmch-2018-000057. eCollection 2019.
PubMed 32148704Dickerson SS, Klingman KJ, Jungquist CR. Common meanings of good and bad sleep in a healthy population sample. Sleep Health. 2016 Sep;2(3):253-259. doi: 10.1016/j.sleh.2016.06.004. Epub 2016 Jul 30.
PubMed 29073430Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10.
PubMed 26613970Campbell, K. A., Orr, E., Durepos, P., Nguyen, L., Li, L., Whitmore, C., ... & Jack, S. M. (2021). Reflexive thematic analysis for applied qualitative health research. The Qualitative Report, 26(6), 2011-2028.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are Persistent Lower Back Pain Patients' Views of Sleep Health Within an Outpatient
- ClinicalTrials.gov ID
- NCT06094517
- Acronym / sponsor ID
- PLBP paitent view sleep Phyiso
- Keywords
- Physiotherapy, Persistent Lower Back Pain, Sleep Disturbance, Lower Back Pain, Chronic Low-back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Chesterfield Royal Hospital NHS Foundation Trust
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 17 Apr 2024 (estimated)
- First posted
- 23 Oct 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 goal of this qualitative is to understand the views and opinions of patients with persistent lower back pain patients who are awaiting physiotherapy treatment with regards sleep their sleep health. The main questions it aims to answer are:
- Identify whether Patients with persistent lower back pain awaiting physiotherapy consider sleep health relevant to their condition.
- Understand whether persistent lower back pain patients awaiting physiotherapy consider sleep health within the remit of Physiotherapy?
- Understand how persistent lower back pain patients may want sleep health to be assessed or managed within an outpatient musculoskeletal Physiotherapy Setting?
Participants will undertake one semi structured interview and complete two secondary outcome measures: Pittsburgh Sleep Quality Index and Pain, Enjoyment of Life and General Activity Scale. Data will be analysed via Thematic Analysis.
Detailed description
Background:Approximately one third of western populations suffer from sleep disturbance at least once a week and with 6-10% meeting the threshold of insomnia (National Institute of Clinical Excellence, 2022). The estimated population of the United Kingdom (UK) affected by insomnia is 37% (Morphy et al., 2007). Diminished sleep is associated with increased pain perceptions, reduced pain thresholds, physical activity levels, immune function, cognition and quality of life. Moreover, a lack of sleep correlates with increased prevalence of diabetes, obesity, cardiovascular disease, depression, and mortality (Medi, Wille \& Hemels, 2017).
Over 90% of patients with Persistent Lower Back Pain (PLBP) receiving physiotherapy are affected by sleep disturbance (Roseen et al., 2020).Conventional Physiotherapy rehabilitation has shown effective in improving sleep quality in patients with PLBP as measured via Pittsburgh Sleep Quality Index (PSQI). However, Eadie et al. (2013) \& Roseen et al., (2020). There is a paucity of research exploring Physiotherapies role within sleep health. Equally, studies specific to Physiotherapies role are mainly reviewed from the clinician's perspective, with a scarceness of studies providing insight into the patient perspective. To date, no studies have canvassed the opinion of patients in Physiotherapy care on the profession's role in sleep health, creating a strong footing for the proposed investigation Physiotherapist place a high value on the importance of sleep health but struggle to provide inventions citing a lack of training, resource and time. The evidence based is heavily survey based and of a quantitative nature, lacking explanation of why barriers exist, warranting further qualitative investigation (Caudwell et al. 2020 and Siengsukon, Nelson \& Turkowitch 2023)
It is unclear how PLBP patients with sleep disturbance want to utilize their time in Physiotherapy care and their perceptions of Physiotherapies role within the management of sleep health (Siengsukon, Nelson \& Turkowitch 2023). The proposed study would be the first to be conducted in the UK, examining PLBP patients' expectations of sleep health management within outpatient MSK physiotherapy setting.
Design and Methods:Qualitative in nature, via individual semi-structured interviews, will allow the study to explore participants' feelings and beliefs (De Jonckheere \& Vaughn, 2019). The study topic is novel in design and will allow the capture of rich data and themes (Lincoln \& Guba, 1985), current evidence base lacks qualitative data, especially from a patient perspective(Caudwell et al. 2020).
Recruitment and Sample Size: Recruitment will occur until the point of data saturation is reached and new themes have stopped emerging. Dickerson, Klingman \& Jungquist (2016) comparable study found that interviewing 29 participants on the "Common meanings of good and bad sleep" met saturation point. Given their much wider focus, it is anticipated that interviewing 8-12 participants would meet data saturation in the proposed study. This will be reviewed for adequacy concurrently with data collection (De Jonckheere \& Vaughn 2019 and Malterud, Siersma \& Guassora, 2016).
Data-Collection: Semi-structured interviews will be directed by the interview guide. Transcriptions will then be reviewed and corresponded to interview notes taken to ensure accuracy. Further secondary outcome measures PSQI and Pain, Enjoyment of Life and General Activity Scale, will be collected prior to interviews via Google Forms Surveys.
Data Analysis: Data analysis will be completed by the principal investigator via a Reflexive Thematic Analysis approach.
- Dataset Familiarisation
- Data Coding
- Initial Theme Generation
- Theme Development and Review
- Theme Refining
- Writing Up
Reflexive Thematic Analysis provides a structured systematic process for the recognition of themes. It recognises the background of the research and celebrates their insight into the topic, allowing for meaningful generation of themes. Although themes should occur multiple times within the data, this approach allows for the relevance and quality of the data provided to best answer the research question as opposed to prevalence alone. To ensure rigour, prior to completing the trial practice interview with Senior Physiotherapist interested in sleep health and reviewed for appropriateness. During the interview and coding processes, a reflective log will be kept by the principal researcher, appraising their performance within the data collection and considering personal bias (Campbell et al., 2021). To ensure consistency, the interviews, initial coding and theme generation will be conducted by the Principal Investigator. Appropriateness will be reviewed by the First Supervisor.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed Group | – | Other: InterviewPatients with persistent lower back pain awaiting Physiotherapy care, undergoing interviews to assess their views of sleep health within and musculoskeletal outpatient Physiotherapy setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified from self-referrals and General Practitioner (GP) referrals to outpatient Musculoskeletal Physiotherapy at Chesterfield Royal Hospital NHS Foundation Trust, Meeting the Inclusion / exclusion criteria.
Key inclusion criteria (3 listed)
- On waiting list for Outpatient MSK Physiotherapy at Chesterfield Royal Hospital NHS Foundation Trust
- PLBP (present ≥ 3 months)
- Patients ≥ 18 years
Key exclusion criteria (7 listed)
- Not fluent in English
- Failure to understand study
- Previous spinal surgery
- Serous spinal pathology such as fractures or metastasis
- Inflammatory Arthritis
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 |
|---|---|---|
| InterviewPersistent Lower Back Pain Patients on waiting list under going a usual care pathway following referral to Physiotherapy will be interviewed for views on sleep health | Other | Observed Group |
Primary outcome
Thematic Analysis
Time frame: Completed one within 2 week of recruitment to trial
Thematic Analysis of Data from semi structured interview
2 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Completed one within 2 week of recruitment to trial
Pain, Enjoyment of Life and General Activity Scale (PEG Scale)
Time frame: Completed one within 2 week of recruitment to trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- BackgroundNational Institute of Clinical Excellence. (2022). Insomnia. CKS. https://cks.nice.org.uk/topics/insomnia/background-information/prevalence
- Background: PubMed 17425223Morphy H, Dunn KM, Lewis M, Boardman HF, Croft PR. Epidemiology of insomnia: a longitudinal study in a UK population. Sleep. 2007 Mar;30(3):274-80.
- Background: PubMed 28579842Medic G, Wille M, Hemels ME. Short- and long-term health consequences of sleep disruption. Nat Sci Sleep. 2017 May 19;9:151-161. doi: 10.2147/NSS.S134864. eCollection 2017.
- Background: PubMed 31667747Roseen EJ, Gerlovin H, Femia A, Cho J, Bertisch S, Redline S, Sherman KJ, Saper R. Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):167-176. doi: 10.1007/s11606-019-05329-4. Epub 2019 Oct 30.
- Background: PubMed 23643716Eadie J, van de Water AT, Lonsdale C, Tully MA, van Mechelen W, Boreham CA, Daly L, McDonough SM, Hurley DA. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial. Arch Phys Med Rehabil. 2013 Nov;94(11):2083-92. doi: 10.1016/j.apmr.2013.04.017. Epub 2013 May 2.
- BackgroundLincoln, Y. S., & Guba, E. G. (1985). Naturalistic inquiry. Sage
- BackgroundCaudwell, L., Himani, H., Khaw, A., Taylor, R., White, J., Rhodes, S., & Skinner, M. (2020). Attitudes and perceptions of health professionals towards sleep health: A systematic review. Physical Therapy Reviews, 25(5-6), 361-380.
- Background: PubMed 37269038Siengsukon CF, Nelson E, Turkowitch D. Barriers and Facilitators to Implementing Sleep Health into Outpatient Physical Therapist Practice: A Survey Study. J Allied Health. 2023 Summer;52(2):e55-e61.
- Background: PubMed 32148704DeJonckheere M, Vaughn LM. Semistructured interviewing in primary care research: a balance of relationship and rigour. Fam Med Community Health. 2019 Mar 8;7(2):e000057. doi: 10.1136/fmch-2018-000057. eCollection 2019.
- Background: PubMed 29073430Dickerson SS, Klingman KJ, Jungquist CR. Common meanings of good and bad sleep in a healthy population sample. Sleep Health. 2016 Sep;2(3):253-259. doi: 10.1016/j.sleh.2016.06.004. Epub 2016 Jul 30.
- Background: PubMed 26613970Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10.
- BackgroundCampbell, K. A., Orr, E., Durepos, P., Nguyen, L., Li, L., Whitmore, C., ... & Jack, S. M. (2021). Reflexive thematic analysis for applied qualitative health research. The Qualitative Report, 26(6), 2011-2028.
- Individual participant dataSharing planned: Undecided. Requests for anonymised core data will be considered upon request by the Principle Investigator Clive Smith ( via emails clivesmith1@nhs.net). Personal details will not be shared other than with responsible parties from Sheffield Hallam University or Chesterfield Royal Hospital NHS Foundation Trust in the case of concern safety concerns.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Lower Back Pain and Sleep Disturbance, run by Sheffield Hallam University.
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 7 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clive Smith, BSc (01246512178, clivesmith1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thematic Analysis (time frame: Completed one within 2 week of recruitment to trial). 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 NCT06094517, which also lists 12 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 23 Oct 2023.