An interventional study of Dilator and Fear-Based Questionnaires in Sexual Pain Disorders, sponsored by University of Florida. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-11-19.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants in this group will complete a home dilator program using levels of pain-related fear to progress through the program.
Device: Dilator · Behavioral: Fear-Based Questionnaires
Participants in this group will complete a standard home program based on dilator manufacturer instructions for use.
Device: Dilator
Both groups will have a home program consisting of dilators which are progressive in size. The standard care group will use manufacturer instructions to progress in size of dilators, while the experimental group will use self-reported levels of fear to progress in size of dilators.
Series of questionnaires used to facilitate emotional awareness associated with vaginal and decreased sexual arousal.
Vaginal Pain sensitivity
A change in pressure pain sensitivity at the vagina using a Wagner Digital Algometer.
Time frame: 40 days
Sexual function
Assessed using the Female Sexual Function Index (FSFI), a 19- item questionnaire that measures desire, arousal, lubrication, orgasm, satisfaction, and pain in women with pelvic pain. This measure has high internal consistency (Cronbach's alpha 0.91-0.97) and good test-retest reliability (r=0.79-0.90).
Time frame: 40 days
Sexual Distress
Assessed using the Female Sexual Distress Scale-Revised (FSDS-R), a 13-item questionnaire that evaluates negative emotions about sexuality and sexual relations. The internal consistency of this measure is high (Cronbach's alpha 0.86- 0.94) with good test retest reliability (ICC= 0.74).
Time frame: 40 days
Partner dynamics
Assessed using the Revised Dyadic Adjustment Scale(RDAS), a 14-item questionnaire that assesses three overarching dimensions of relationships, including Consensus, Satisfaction, and Cohesion. This measure has high internal consistency (Cronbach's alpha= 0.90).
Time frame: 40 days
Plan to share: No
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University of Florida