The Role of Pain-related Fear in Sexual Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Vaginal Pain sensitivity
研究概览
简要总结
The purpose of this study is the evaluate the extent to which an intervention aimed at reducing pain-related fear affects sexual function and pain sensitivity compared to usual care.
详细描述
The overarching goal of this work is to identify the mechanisms underpinning sexual pain in women. Women with sexual pain exhibit higher vaginal pain sensitivity and lower levels of sexual desire and arousal compared to pain-free women. As a result of pain, sexual intercourse is avoided. Previous work in this area has examined a wide variety of interventions for sexual pain but has not examined how vaginal pain sensitivity and resulting sexual dysfunction may be mediated by pain-related fear. The study team proposes that a standardized exposure intervention that directly targets pain-related fear will in turn reduce vaginal pain sensitivity and translate to clinically meaningful changes in sexual function. The study team will assign women with sexual pain to receive a home-based, patient-controlled exposure intervention or standardized home-based home program. The specific aims of this proposal are: 1) To evaluate the extent to which pain-related fear mediates vaginal pain sensitivity in women with sexual pain; 2) To evaluate the extent to which graded exposure translates to changes in sexual function and partner dynamics. The completion of this work will provide us with a better understanding of the mechanisms underpinning sexual pain and specifically, how pain-related fear influences vaginal pain sensitivity and sexual function.
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 (Investigator)
盲法说明
An investigator who will not interact with study participants will perform the random intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with sexual pain >= 6 months
- •Appropriate to use vaginal dilators
- •The ability to read English and understand the informed consent form and screening questions
- •The ability and willingness to follow all requirements of the study including following all directions and completion of daily pain reports
- •Signed informed consent
- •Are sexually active (have had intercourse at least twice in the last 30 days)
- •Pain-related fear of intercourse greater than 50 on the numerical fear rating scale
排除标准
- •Physical, psychological and medical issues, encountered during routine care that are felt insufficient for trial participation (physician discretion), such as poor mental status or neurological deficit limiting participation physically or cognitively (Mini-mental state exam less than 20).
- •Women with sexual pain who are not sexually active (have not had intercourse at least twice in the last 30 days)
- •Participants who use narcotic pain medication
- •Participants diagnosed with a major depressive disorder
- •Participants who exhibit signs and symptoms of infection, malignancy, or other conditions identified by a member of the study team that may be contraindications to the use of dilators
- •Unable to readily access computer with Internet for reporting on daily fear levels and dilator size
- •Pain-related fear of intercourse less than 50 on the numerical fear rating scale
- •Women who are pregnant
- •Participants who report a history of sexual abuse or trauma.
研究组 & 干预措施
Fear-based Dilator Progression group
Participants in this group will complete a home dilator program using levels of pain-related fear to progress through the program.
干预措施: Dilator (Device)
Fear-based Dilator Progression group
Participants in this group will complete a home dilator program using levels of pain-related fear to progress through the program.
干预措施: Fear-Based Questionnaires (Behavioral)
Standard Dilator Progression Group
Participants in this group will complete a standard home program based on dilator manufacturer instructions for use.
干预措施: Dilator (Device)
结局指标
主要结局
Vaginal Pain sensitivity
时间窗: 40 days
A change in pressure pain sensitivity at the vagina using a Wagner Digital Algometer.
次要结局
- Sexual function(40 days)
- Sexual Distress(40 days)
- Partner dynamics(40 days)