Status:
WITHDRAWN
The Role of Pain-related Fear in Sexual Pain
Lead Sponsor:
University of Florida
Conditions:
Sexual Pain Disorders
Eligibility:
FEMALE
18-100 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03385603
Start Date
May 7 2018
End Date
November 15 2018
Last Update
November 19 2018
Active Locations (1)
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1
UF Health at Springhill
Gainesville, Florida, United States, 32606