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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

792 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-17

Study Completion Date

2026-02-01

Brief Summary

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Inflammatory Bowel Disease (IBD) is a chronic, relapsing and remitting disease that can greatly impact health and personal well-being. Sexual health, relationships and intimacy have been raised as key concerns for those living with the disease. Men's sexual health and well-being has been identified as a neglected area. This study will lead to the development of an intervention that will help nurses to improve the assessment and care of the sexual health and well-being needs of men with IBD.

Detailed Description

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This research aims to develop an intervention to help nurses improve the assessment and care of the sexual health needs of men with Inflammatory Bowel Disease (IBD). This is a long-term digestive condition that is often diagnosed between the ages of 15-30 years. Patients often have bloody diarrhoea, abdominal pain, incontinence, and fatigue.

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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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Online and face to face co-production workshops

Interventions

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Questionnaire

Online questionnaire designed by the investigatory team.

Intervention Type OTHER

Focus group

Online focus group

Intervention Type OTHER

Interview

Online semi-structured interview

Intervention Type OTHER

Workshop

Online and face to face co-production workshops

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

A diagnosis of Crohn's Disease, Ulcerative Colitis or IBD-U who identifies as male OR Currently in (or in the last 5 years) an intimate partnership with a person who identifies as male and has a diagnosis for Crohn's Disease, Ulcerative Colitis or IBD-U.

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

Unable to provide informed consent Less than 18 years old Does not speak English Not able to participate in the research activity (questionnaire, interview, focus group or workshop)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of York

OTHER

Sponsor Role collaborator

York St John University

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

York Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 40913018 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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MenSH-IBD

Identifier Type: -

Identifier Source: org_study_id

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