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临床试验/NCT02958176
NCT02958176已完成不适用

Autonomic Imbalance and Female Sexual Arousal Disorder: The Identification of Heart Rate Variability Level as a Risk Factor and Treatment Target

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)

研究概览

简要总结

Low resting heart rate variability (HRV) has been associated with sexual arousal problems and overall sexual dysfunction in women. Research has indicated that HRV biofeedback leads to increases in HRV as well as improvements in symptoms associated with several psychological disorders, some of which are comorbid with sexual arousal problems in women. Autogenic training also facilitates increases in HRV and was recently associated with acute increases in sexual arousal among sexually healthy women. The primary aim of the current study is to examine the efficacy of HRV biofeedback, with and without autogenic training, for the treatment of female sexual arousal disorder (FSAD).

详细描述

Women who meet ICD-10-CM diagnostic criteria for FSAD will be recruited and randomized into one of three conditions, HRV biofeedback (n = 25), HRV biofeedback plus autogenic training (n = 25), or wait-list control (n = 15). All participants will complete a baseline assessment, during which their resting state HRV and vaginal pulse amplitude (VPA) will be measured. The participants in the two biofeedback conditions will receive training in HRV biofeedback from the experimenter, and they will be provided with the materials necessary to guide self-practice in HRV biofeedback at home. Participants in these two conditions will be instructed to engage in at-home HRV biofeedback (with or without autogenic training) at least 5 times over a period of two weeks, during which they will report levels of arousal in a sexual activity diary. Participants in the wait-list control condition will report levels of arousal in a sexual activity diary. After two weeks, participants in all three conditions will return to the laboratory, where their physiological and psychological sexual arousal will be measured. Over the next two weeks, participants in the two biofeedback conditions will be asked to complete 5 more self-guided biofeedback sessions along with the sexual activity diary. Participants in all three conditions will return to the lab for a final assessment to measure post-treatment HRV and VPA levels as well as psychological sexual arousal. To our knowledge, this study will be the first randomized controlled trial of HRV biofeedback in women with sexual arousal problems. If the intervention increases arousal in this population, this study may offer a promising cost-effective psychosocial treatment for women with sexual arousal problems.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Premenopausal (18-40 years)
  • Fluent in English
  • Heterosexual or bisexual
  • Score of 26.55 or less on the Female Sexual Function Index (FSFI)
  • Current sexual arousal dysfunction
  • Ownership of an Elite HRV compatible device (recent iPhone, iPad, or Android)

排除标准

  • Pregnant or breastfeeding
  • History of or current sexually transmitted infections
  • History of major pelvic surgery
  • History of childhood sexual abuse
  • Currently taking androgens, estrogens, or other medical treatments to enhance sexual arousal
  • Current psychosis
  • If on antidepressants or antihypertensives, must be stabilized for at least 3 months

研究组 & 干预措施

Wait List

No Intervention

Wait list control

HRV Biofeedback

Experimental

At home HRV biofeedback using mobile device

干预措施: HRV Biofeedback (Behavioral)

HRV Biofeedback with Autogenic Training

Experimental

At home HRV biofeedback using mobile device plus autogenic training recording

干预措施: HRV Biofeedback (Behavioral)

HRV Biofeedback with Autogenic Training

Experimental

At home HRV biofeedback using mobile device plus autogenic training recording

干预措施: Autogenic Training (Behavioral)

结局指标

主要结局

Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)

时间窗: One month

Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)

时间窗: Two months

Physiological sexual arousal assessed by vaginal photoplethysmography

时间窗: One month

次要结局

  • Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)(Two months)
  • Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)(Two months)
  • Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)(Two months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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