Sexual Pain DisordersNCT03385603
The Role of Pain-related Fear in Sexual Pain
A study testing Dilator and Fear-Based Questionnaires in people with Sexual Pain Disorders, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Sexual Pain Disorders
- What is being tested?
- Dilator and Fear-Based Questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Dilator, Fear-Based Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 QuestionnairesBehavioural
Series of questionnaires used to facilitate emotional awareness associated with vaginal and decreased sexual arousal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dilator; Behavioral: 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. Receives: Device: Dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Pain sensitivity
A change in pressure pain sensitivity at the vagina using a Wagner Digital Algometer.
Measured: 40 days
Secondary outcomes (3)
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).
Measured: 40 days
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).
Measured: 40 days
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).
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start7 May 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Why it stopped: No individuals met eligibility or were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Pain DisordersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive one of two treatments.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meryl Alappattu, DPT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385603
- Sponsor's protocol ID
- IRB201702214
- Status last verified
- Nov 2018
- First submitted
- 20 Dec 2017
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pain-related Fear in Sexual Pain
- ClinicalTrials.gov ID
- NCT03385603
- Acronym / sponsor ID
- IRB201702214
- Conditions
- Sexual Pain Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No individuals met eligibility or were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive one of two treatments.
| Arm | Type | Receives |
|---|---|---|
| Fear-based Dilator Progression group | Experimental | Device: Dilator, Behavioral: Fear-Based QuestionnairesParticipants in this group will complete a home dilator program using levels of pain-related fear to progress through the program. |
| Standard Dilator Progression Group | Active comparator | Device: DilatorParticipants in this group will complete a standard home program based on dilator manufacturer instructions for use. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DilatorBoth 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. | Device | Fear-based Dilator Progression group, Standard Dilator Progression Group |
| Fear-Based QuestionnairesSeries of questionnaires used to facilitate emotional awareness associated with vaginal and decreased sexual arousal. | Behavioural | Fear-based Dilator Progression group |
Primary outcome
Vaginal Pain sensitivity
Time frame: 40 days
A change in pressure pain sensitivity at the vagina using a Wagner Digital Algometer.
3 secondary outcomes
Sexual function
Time frame: 40 days
Sexual Distress
Time frame: 40 days
Partner dynamics
Time frame: 40 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryl Alappattu, DPT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dilator and Fear-Based Questionnaires in people with Sexual Pain Disorders, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Pain sensitivity (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.