Surface and Deep DyspareuniaNCT07658703
Physiotherapeutic Approach to Superficial and Deep Dyspareunia in Women With Chronic Pelvic Pain: Comparison Between In-person and Telehealth Care.
A study testing Face-to-face treatment and Telecare in people with Surface and Deep Dyspareunia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Adequate sexual function is considered an important factor in satisfaction and overall quality of life for both men and women. It is estimated 16% to 40% of women suffer from some form of sexual dysfunction, which is currently considered a public health problem and its investigation is recommended because it causes… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surface and Deep Dyspareunia
- What is being tested?
- Face-to-face treatment and Telecare
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 16 May 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with CPP and deep or shallow penetration dyspareunia;
- Over 18 years of age;
- Willingness to voluntarily participate in the study, accepting randomization to either of the two treatment arms;
- Signature of the Free and Informed Consent Form (FICF).
Who cannot join
- Women with penetrative dyspareunia without pelvic floor muscle spasm;
- Women without an active sex life
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ribeirão Preto Clinical Hospital
Ribeirão Preto, São Paulo, 14048-900
About this study
Adequate sexual function is considered an important factor in satisfaction and overall quality of life for both men and women. It is estimated 16% to 40% of women suffer from some form of sexual dysfunction, which is currently considered a public health problem and its investigation is recommended because it causes significant changes in the quality of life of these women. Among the painful disorders, genitopelvic pain, which includes dyspareunia, vaginismus and vulvodynia, dyspareunia stands out, which involves the appearance of pain during or after sexual intercourse, directly affecting physical health, as well as sexual and mental well-being. Among the treatment techniques for dyspareunia in women with chronic pelvic pain, there is the Thiele massage, which provides an inhibitory effect on muscle tension caused by spasms, relaxing, stretching and relieving coital pain. In this sense, we know that physiotherapy treatment has an important role in improving pain symptoms, since musculoskeletal dysfunction may be present in women with dyspareunia, which makes it relevant to verify whether the approach via telecare would have the same effectiveness as the in-person technique that has scientific proof, since through telecare the woman would not be exposed to the risks that are inherent to going to an outpatient clinic, it could cover more women and this would also bring a greater cost-benefit to the unified health system.
- Conditions
- Surface and Deep Dyspareunia
- Being tested
- Face-to-face treatment, Telecare
- Keywords
- Dyspareunia, Chronic pelvic pain, Telecare, Physiotherapy, Massage
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face treatmentProcedure or surgery
Massage in the direction of the muscle fibers with a pressure tolerable for the patient for 5 minutes. The treatment will be carried out in the outpatient clinic by a previously trained physiotherapist.
TelecareProcedure or surgery
Massage in the direction of the muscle fibers with a pressure tolerable for the patient for 5 minutes. The treatment will be carried out by the patient at home and guided by a previously trained physiotherapist via teleconsultation.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face treatment | Active comparator | Treatment through face-to-face outpatient care Receives: Procedure: Face-to-face treatment |
| Telecare | Active comparator | Teleservice via video call Receives: Procedure: Telecare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (EAV)
The visual analog scale (VAS) for pain is the most widely used unidimensional scale in clinical practice due to its feasibility, speed, and clinical application. It measures pain from 0 to 10, with higher scores indicating greater pain.
Measured: From acceptance to participate in the study until the end in 10 weeks in the reassessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start16 May 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surface and Deep DyspareuniaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Responsible party
- Principal investigator, Hellen Maria Feitoza De Almeida, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658703
- Sponsor's protocol ID
- 7.460.314
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPR collected, all IPR that underpins the results of a publication.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapeutic Approach to Superficial and Deep Dyspareunia in Women With Chronic Pelvic Pain: Comparison Between In-person and Telehealth Care.
- ClinicalTrials.gov ID
- NCT07658703
- Acronym / sponsor ID
- 7.460.314
- Conditions
- Surface and Deep Dyspareunia
- Keywords
- Dyspareunia, Chronic pelvic pain, Telecare, Physiotherapy, Massage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Study start
- 16 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Jun 2026 (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.
Adequate sexual function is considered an important factor in satisfaction and overall quality of life for both men and women. It is estimated 16% to 40% of women suffer from some form of sexual dysfunction, which is currently considered a public health problem and its investigation is recommended because it causes significant changes in the quality of life of these women. Among the painful disorders, genitopelvic pain, which includes dyspareunia, vaginismus and vulvodynia, dyspareunia stands out, which involves the appearance of pain during or after sexual intercourse, directly affecting physical health, as well as sexual and mental well-being. Among the treatment techniques for dyspareunia in women with chronic pelvic pain, there is the Thiele massage, which provides an inhibitory effect on muscle tension caused by spasms, relaxing, stretching and relieving coital pain. In this sense, we know that physiotherapy treatment has an important role in improving pain symptoms, since musculoskeletal dysfunction may be present in women with dyspareunia, which makes it relevant to verify whether the approach via telecare would have the same effectiveness as the in-person technique that has scientific proof, since through telecare the woman would not be exposed to the risks that are inherent to going to an outpatient clinic, it could cover more women and this would also bring a greater cost-benefit to the unified health system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-face treatment | Active comparator | Procedure: Face-to-face treatmentTreatment through face-to-face outpatient care |
| Telecare | Active comparator | Procedure: TelecareTeleservice via video call |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women diagnosed with CPP and deep or shallow penetration dyspareunia;
- Over 18 years of age;
- Willingness to voluntarily participate in the study, accepting randomization to either of the two treatment arms;
- Signature of the Free and Informed Consent Form (FICF).
Key exclusion criteria (2 listed)
- Women with penetrative dyspareunia without pelvic floor muscle spasm;
- Women without an active sex life
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 |
|---|---|---|
| Face-to-face treatmentMassage in the direction of the muscle fibers with a pressure tolerable for the patient for 5 minutes. The treatment will be carried out in the outpatient clinic by a previously trained physiotherapist. | Procedure or surgery | Face-to-face treatment |
| TelecareMassage in the direction of the muscle fibers with a pressure tolerable for the patient for 5 minutes. The treatment will be carried out by the patient at home and guided by a previously trained physiotherapist via teleconsultation. | Procedure or surgery | Telecare |
Primary outcome
Visual Analog Scale (EAV)
Time frame: From acceptance to participate in the study until the end in 10 weeks in the reassessment.
The visual analog scale (VAS) for pain is the most widely used unidimensional scale in clinical practice due to its feasibility, speed, and clinical application. It measures pain from 0 to 10, with higher scores indicating greater pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Plataforma Brasil is the one that approves the research of the ethics and research committeeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPR collected, all IPR that underpins the results of a publication.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face treatment and Telecare in people with Surface and Deep Dyspareunia, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (EAV) (time frame: From acceptance to participate in the study until the end in 10 weeks in the reassessment.). 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 22 Jun 2026.