The Role of Pain-related Fear in Sexual Pain

NCT ID: NCT03385603

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2018-11-15

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.

Conditions

Sexual Pain Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dilator

Intervention Type: DEVICE

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.

Fear-Based Questionnaires

Intervention Type: BEHAVIORAL

Series of questionnaires used to facilitate emotional awareness associated with vaginal and decreased sexual arousal.

Standard Dilator Progression Group

Participants in this group will complete a standard home program based on dilator manufacturer instructions for use.

Group Type: ACTIVE_COMPARATOR

Dilator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Fear-Based Questionnaires

Series of questionnaires used to facilitate emotional awareness associated with vaginal and decreased sexual arousal.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meryl Alappattu, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health at Springhill

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201702214

Identifier Type: -

Identifier Source: org_study_id