The Role of Pain-related Fear in Sexual Pain

Not Applicable

Withdrawn

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Standard Dilator Progression Group	Dilator	Participants in this group will complete a standard home program based on dilator manufacturer instructions for use.
Fear-based Dilator Progression group	Dilator	Participants in this group will complete a home dilator program using levels of pain-related fear to progress through the program.
Fear-based Dilator Progression group	Fear-Based Questionnaires	Participants in this group will complete a home dilator program using levels of pain-related fear to progress through the program.

Primary Outcome Measures

Name	Time	Method
Vaginal Pain sensitivity	40 days	A change in pressure pain sensitivity at the vagina using a Wagner Digital Algometer.

Secondary Outcome Measures

Name	Time	Method
Sexual function	40 days	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).
Sexual Distress	40 days	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).
Partner dynamics	40 days	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).

Locations (1): UF Health at Springhill
🇺🇸
Gainesville, Florida, United States