Clinical trial NCT03385603: The Role of Pain-related Fear in Sexual Pain
Official title: The Role of Pain-related Fear in Sexual Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sexual Pain Disorders
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive one of two treatments.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vaginal Pain sensitivity
timeFrame: 40 days
Secondary outcomes:
measure: Sexual function
timeFrame: 40 days
measure: Sexual Distress
timeFrame: 40 days
measure: Partner dynamics
timeFrame: 40 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at Springhill
state: Florida
Study officials:
affiliation: University of Florida
name: Meryl Alappattu, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: