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临床试验/NCT06397664
NCT06397664已完成不适用

A Quantitative and Qualitative Study on the Impact of Chronic Adolescent Skin Conditions on Sexual Health

Oxford University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2024年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Scores from the IIEF (International Index of Erectile Function)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
17 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Scores from the IIEF (International Index of Erectile Function)

时间窗: Baseline (Retrospective study)

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.

Scores from the FSFI (Female Sexual Function Index)

时间窗: Baseline (Retrospective study)

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.

Scores from the modified T-QOL (Teenager's Quality of Life Index) to 1 year

时间窗: Baseline (Retrospective study)

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.

Scores from the PHQ-9 (Patient Health Questionnaire)

时间窗: Baseline (Retrospective study)

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.

Scores from the GAD-2 (Generalised Anxiety Disorder 2-item)

时间窗: Baseline (Retrospective study)

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.

次要结局

  • A narrative synthesis detailing risk factors impacting sexual function in adolescents with chronic skin conditions(Baseline (Retrospective study))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tess Mcpherson

Primary Investigator

Oxford University Hospitals NHS Trust

研究点 (1)

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