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Can a Mind-Body approach ease chronic vulvar pain?

NCT ID NCT06981611

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial evaluates a multimodal treatment for provoked vulvodynia, a condition causing pain during touch or insertion. The treatment combines education, pelvic floor relaxation, and cognitive-behavioral strategies to address both physical and psychological aspects. Women aged 18-40 with provoked vulvodynia will receive 11 sessions over four months, including partner involvement in some sessions. The study aims to assess feasibility, effects on pain and psychosexual health, and the potential for implementation in healthcare settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A multimodal behavioral treatment combining education, vulva care, lubrication exercises, pelvic floor relaxation, and cognitive-behavioral work on pain, sex, and communication.
What this could lead to
If successful, this could establish an effective, integrated treatment for provoked vulvodynia, potentially improving pain and psychosexual health for many women.
What could go wrong
This is a small, early feasibility study, so results may not be conclusive or generalizable. The treatment involves multiple sessions and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Biological sex: Female 18-40 years old Provoked vulvodynia Exclusion Criteria: * Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis) * Ongoing pregnancy * Childbirth within the last year * Post-traumatic stress disorder (PTSD) related to sexual trauma * Insufficient mastery of the Swedish language * No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment

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Conditions

The condition(s) this trial relates to.

Chronic Pain Color Vision Defects vulvodynia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Karlstad University

    Karlstad, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.