NCT03385603

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

December 20, 2017

Last Update Submit

November 15, 2018

Conditions

Sexual Pain Disorders

Outcome Measures

Primary Outcomes (1)

  • Vaginal Pain sensitivity

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

    40 days

Secondary Outcomes (3)

  • Sexual function

    40 days

  • Sexual Distress

    40 days

  • Partner dynamics

    40 days

Study Arms (2)

Fear-based Dilator Progression group

EXPERIMENTAL

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

Device: DilatorBehavioral: Fear-Based Questionnaires

Standard Dilator Progression Group

ACTIVE COMPARATOR

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

Device: Dilator

Interventions

DilatorDEVICE

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 Dilator Progression groupStandard Dilator Progression Group
Fear-Based QuestionnairesBEHAVIORAL

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

Fear-based Dilator Progression group

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health at Springhill

Gainesville, Florida, 32606, United States

Location

Study Officials

  • Meryl Alappattu, DPT, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
An investigator who will not interact with study participants will perform the random intervention assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive one of two treatments.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

May 7, 2018

Primary Completion

November 15, 2018

Study Completion

November 15, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)