Developing an Intervention to Help Nurses Improve Sexual Healthcare in Men With Inflammatory Bowel Disease
NCT ID: NCT06562751
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
792 participants
OBSERVATIONAL
2024-10-17
2026-02-01
Brief Summary
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Detailed Description
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When severe, the disease can lead to hospital admission and surgery. There is growing recognition that IBD can negatively affect sexual health and impact on patients' relationships and quality of life, but men's needs have been neglected in research. Men report that their sexual health is rarely discussed at National Health Service (NHS) IBD clinic appointments, and specialist information and support are lacking. In this study the investigators will work with men with IBD, the partners of men with IBD, nurses, and other healthcare professionals to develop a nursing intervention that addresses this unmet need through information, assessment, and support.
This study consists of three main parts which have been labelled workstreams. In Workstream One the investigators will identify how the sexual health of men with IBD is currently assessed and cared for in the NHS using three large scale surveys that will include; (1) NHS Trusts (2) Nurses (3) People with IBD.
In Workstream Two the investigators will gather ideas on appropriate ways to improve the healthcare of men with IBD by conducting interviews with men with IBD and partners of men with IBD. The investigators will also conduct focus groups with healthcare professionals to hear their ideas of how services can be improved.
In Workstream Three the investigators will hold a series of workshops with patients and healthcare professionals to develop an intervention and consider how and why it could help patients.
The design of the study has been developed with a patient advisory group and input from IBD health professionals.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Survey 1 (National Health Service Inflammatory Bowel Disease services)
A survey designed by the investigators to ascertain current Inflammatory Bowel Disease service provision for sexual healthcare. A representative from each service will complete one online survey that should take approximately 15 minutes to complete.
Questionnaire
Online questionnaire designed by the investigatory team.
Survey 2 (Inflammatory Bowel Disease nurses survey)
A survey designed by the investigators to ascertain current nursing practice for sexual healthcare within Inflammatory Bowel Disease (IBD) services. Registered nurses working with people with IBD will complete one online survey that should take approximately 15 minutes to complete.
Questionnaire
Online questionnaire designed by the investigatory team.
Survey 3 (men with IBD)
A survey designed by the investigators to ascertain the needs of men with Inflammatory Bowel Disease (IBD). Men with a diagnosis of IBD will complete one online survey that should take approximately 15 minutes to complete.
Questionnaire
Online questionnaire designed by the investigatory team.
Interviews
Men with a diagnosis of Inflammatory Bowel Disease (IBD) and the partners of men with IBD will undertake online, semi-structured interviews that will last no longer than 60 minutes. Participants can be interviewed with their partner or individually. Participants without a partner or whose partner does not wish to be interviewed will be interviewed individually.
Interview
Online semi-structured interview
Focus Groups
Healthcare professionals and appropriate stakeholders (for example charitable organisations) will participate in focus groups. Each focus group will contain 6-8 members. There will be three groups in total.
Focus group
Online focus group
Co-production workshops
A group of 8-12 inclusive of men with IBD, the partners of men with IBD and healthcare professionals and appropriate stakeholders will participate in three co-production workshops to develop a prototype intervention and logic model to patient benefit.
Workshop
Online and face to face co-production workshops
Interventions
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Questionnaire
Online questionnaire designed by the investigatory team.
Focus group
Online focus group
Interview
Online semi-structured interview
Workshop
Online and face to face co-production workshops
Eligibility Criteria
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Inclusion Criteria
OR An NHS employee whose current employment involves oversight of the delivery and provision of a secondary care IBD patient service within their employing organisation. This may be a healthcare professional or non-clinical manager.
OR A registered nurse who as part of their current role is responsible of the provision of care to patients with IBD.
OR A health professional registered with the GMC, NMC or HCPC whose professional role is considered part of the IBD multidisciplinary team. Currently or previously employed in a role that directly provides care, support or advice to men with a diagnosis of IBD.
OR A representative of a charitable, not-for profit, professional, public or governmental organisation that is engaged with men who suffer from long term conditions or IBD specifically.
Exclusion Criteria
18 Years
MALE
No
Sponsors
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University of York
OTHER
York St John University
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
York Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Sara Ma, MSc
Role: PRINCIPAL_INVESTIGATOR
York St John University
Locations
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Sarah Ma
York, North Yorkshire, United Kingdom
Countries
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References
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Ma S, Forshaw G, Kanaan M, Knapp P, Robinson W, Selinger C, Galdas P. Developing an Intervention to Improve Sexual Health Assessment and Care in Men With Inflammatory Bowel Disease. J Adv Nurs. 2025 Sep 5. doi: 10.1111/jan.70199. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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MenSH-IBD
Identifier Type: -
Identifier Source: org_study_id
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