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The Role of Pain-related Fear in Sexual Pain

Primary Purpose

Sexual Pain Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dilator
Fear-Based Questionnaires
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Pain Disorders

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UF Health at Springhill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fear-based Dilator Progression group

Standard Dilator Progression Group

Arm Description

Participants in this group will complete a home dilator program using levels of pain-related fear to progress through the program.

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

Outcomes

Primary Outcome Measures

Vaginal Pain sensitivity
A change in pressure pain sensitivity at the vagina using a Wagner Digital Algometer.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
December 20, 2017
Last Updated
November 15, 2018
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03385603
Brief Title
The Role of Pain-related Fear in Sexual Pain
Official Title
The Role of Pain-related Fear in Sexual Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No individuals met eligibility or were enrolled.
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Pain Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive one of two treatments.
Masking
Investigator
Masking Description
An investigator who will not interact with study participants will perform the random intervention assignment.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fear-based Dilator Progression group
Arm Type
Experimental
Arm Description
Participants in this group will complete a home dilator program using levels of pain-related fear to progress through the program.
Arm Title
Standard Dilator Progression Group
Arm Type
Active Comparator
Arm Description
Participants in this group will complete a standard home program based on dilator manufacturer instructions for use.
Intervention Type
Device
Intervention Name(s)
Dilator
Intervention Description
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
Behavioral
Intervention Name(s)
Fear-Based Questionnaires
Intervention Description
Series of questionnaires used to facilitate emotional awareness associated with vaginal and decreased sexual arousal.
Primary Outcome Measure Information:
Title
Vaginal Pain sensitivity
Description
A change in pressure pain sensitivity at the vagina using a Wagner Digital Algometer.
Time Frame
40 days
Secondary Outcome Measure Information:
Title
Sexual function
Description
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
Title
Sexual Distress
Description
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
Title
Partner dynamics
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryl Alappattu, DPT, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health at Springhill
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Role of Pain-related Fear in Sexual Pain

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