Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in quality of actual and perceived sexual health for females
研究概览
简要总结
In this study patients with Multiple Sclerosis or Spinal Lesions will participate in two different types of treatments that aim to improve sexual and sentimental life. Behavioral (via questionnaires) and brain (via high-density electroencephalogram) effects associated with treatment will be studied.
详细描述
People with neurological diseases can experience sexual disorders that can affect their quality of life. There are cognitive treatments to improve these aspects, but their effectiveness is not clear. The aim of this study is to test the potential efficacy of two treatments (mindfulness and sezual therapy) in two neurological populations (patients with multiple sclerosis and patients with spinal injury). To verify the effects of the treatment, questionnaires and brain activity measurements, measured by electroencephalogram, will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medical diagnosis of MS or spinal injury.
- •ability to sign informed consent.
排除标准
- •other relevant previous neurological or psychiatric pathologies.
研究组 & 干预措施
Sexual therapy
In the sessions a series of questions will be proposed to the subject, who will be free to answer or not, being able to express questions in turn. The sessions will last about 45 minutes, and will be held once a week, for a total of 6 sessions.
干预措施: Therapy (Behavioral)
Mindfulness
During the mindfulness treatment the subjects will be subjected to sessions in which they will be invited to relax, to become aware of the present moment, of their body, through exercises that involve breathing, attention, and visualization of the body.
The sessions will last about 45 minutes, and will be held once a week, for a total of 6 sessions.
干预措施: Therapy (Behavioral)
结局指标
主要结局
Changes in quality of actual and perceived sexual health for females
时间窗: Before and after treatment (circa 6 weeks)
Assessed by means of a standardized questionnaire Female Sexual Dysfunction Questionnaire (Filocamo et al., 2014). 19 questions with 6 choices each. No maximum or minimum score defined. The experimenter evaluates the changes across sessions. This will be aggregated to other outcomes using factor analysis
Changes in quality of actual and perceived sexual health for males
时间窗: Before and after treatment (circa 6 weeks)
Assessed by means of a standardized questionnaire MSHQ- (The Male Sexual Health Questionnaire). Questionnaire on male sexual health (Ugolini, \& Pescatori, 2005). 25 questions with 5 or 6 choices each. No maximum or minimum score defined. The experimenter evaluates the changes across sessions. This will be aggregated to other outcomes using factor analysis
Changes in erectile function
时间窗: Before and after treatment (circa 6 weeks)
Assessed by means of a standardized questionnaire IIEF5- (International Index of Erectile Function). Questionnaire aimed at calculating the International Index of Erectile Function (Rosen et al., 1997). 5 questions with scores 1 to 5. Outcome range 5-25. Lower scores indicate poorer outcomes. This will be aggregated to other outcomes using factor analysis
Changes in intimacy and sexuality
时间窗: Before and after treatment (circa 6 weeks)
Assessed by means of a standardized questionnaire MSISQ-15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire). Questionnaire on Intimacy and Sexuality in People with a Medullary Injury (Monti et al., 2020). 15 items with scores 1 to 5 each. Outcome range 15-75. Higher scores indicate poorer outcomes. This will be aggregated to other outcomes using factor analysis
次要结局
- Changes in Mutual Information between brain regions after viewing neutral and erotic videos(Before and after treatment (circa 6 weeks))
- Psychological Well-Being(Before and after treatment (circa 6 weeks))
- Anxiety(Before and after treatment (circa 6 weeks))
- Changes in the assessment of the emotional response after viewing neutral and erotic videos(Before and after treatment (circa 6 weeks))
- Changes in brain spectral power after viewing neutral and erotic videos(Before and after treatment (circa 6 weeks))
研究者
Daniele Marinazzo
Scientific collaborator
IRCCS San Camillo, Venezia, Italy