- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06397664
The Impact of Chronic Adolescent Skin Conditions on Sexual Health
A Quantitative and Qualitative Study on the Impact of Chronic Adolescent Skin Conditions on Sexual Health
Background: Skin conditions are common in young people and are known to adversely affect emotional well-being and quality of life in a range of ways, including negative impact on intimate relationships. However, despite its importance, it has been shown that dermatology consultations rarely address issues like genital skin involvement or sexual dysfunction. Furthermore, there is currently very little data on the scale of the problem, risk factors, psychological impact of skin on sexual function or understanding of the most appropriate ways to manage it in this age group.
Research aims: The Dermatology department at Oxford University Hospitals National Health Service Trust (Oxford, United Kingdom) have already set up an award-winning specialist dermatology service for young people with embedded psychological support. This study further explores how services can be improved by evaluating the impact of chronic skin conditions on quality of life and sexual dysfunction in adolescents. By identifying the associated risk factors, recommendations can be made to effectively meet the physical and mental health needs of adolescents.
Design and methods: The study will gain perspectives from follow-up patients aged 17 - 25 years seen by the Dermatology departments in Oxford University Hospitals National Health Service Trust (Oxford, United Kingdom). They will complete an online anonymous survey to share how their skin condition affects their quality of life, including sex and intimacy, and how services can be improved to meet their needs. In-depth interviews will then be conducted in those who volunteer, to better understand the nuances of unmet needs. Participation is voluntary.
Dissemination: Results of the research will be disseminated by national and international conferences, publications in academic dermatology journals and collaborations with other NHS departments. Improvements will be made to the local adolescent dermatology service as a result and shared via local meetings and posters.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oxford, United Kingdom, OX3 7LE
- Churchill Hospital, Oxford University Hospitals NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 17-25 (inclusive).
- Diagnosed with a long-term skin condition and seen as a follow-up patient in the clinic.
- Recruited from Paediatric/Adolescent, General and Acne clinics under the Oxford University Hospitals National Health Service Trust Dermatology Department.
- Fluent in English (reading and writing).
Exclusion Criteria:
- No informed consent was given to participate in the study or use the data for research purposes.
- No capacity to make an informed decision to consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Scores from the modified T-QOL (Teenager's Quality of Life Index) to 1 year
Time Frame: Baseline (Retrospective study)
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T-QOL is modified to 1 year to reflect the impact of chronic skin conditions. Scores range from 0 (least impairment on quality of life) to 36 (greatest impairment on quality of life). It is self-reported and validated. |
Baseline (Retrospective study)
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Scores from the IIEF (International Index of Erectile Function)
Time Frame: Baseline (Retrospective study)
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IIEF reflects 5 domains - male erectile function (maximum score 30) and intercourse satisfaction (maximum score 15), orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction (maximum scores of 10). Low scores correlate with worse outcomes. It is self-reported and validated. |
Baseline (Retrospective study)
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Scores from the FSFI (Female Sexual Function Index)
Time Frame: Baseline (Retrospective study)
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FSFI reflects 6 domains - female sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. All domains have a maximum score of 6 and can be totalled. Low scores correlate with worse outcomes. It is self-reported and validated. |
Baseline (Retrospective study)
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Scores from the PHQ-9 (Patient Health Questionnaire)
Time Frame: Baseline (Retrospective study)
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PHQ-9 is a diagnostic tool to monitor depression severity. Scores range from 0 (no depression) to 27 (severe depression). It is self-reported and validated. |
Baseline (Retrospective study)
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Scores from the GAD-2 (Generalised Anxiety Disorder 2-item)
Time Frame: Baseline (Retrospective study)
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GAD-2 initially screens for generalised anxiety disorder. The scores range from 0 (unlikely to have GAD) to 6 (most likely to have GAD). It is self-reported and validated. |
Baseline (Retrospective study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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A narrative synthesis detailing risk factors impacting sexual function in adolescents with chronic skin conditions
Time Frame: Baseline (Retrospective study)
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A narrative synthesis derived from the thematic analysis of at least 20 in-depth semi-structured interviews, using a constant comparison and mind-mapped approach.
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Baseline (Retrospective study)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 329926
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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