Actively Recruiting

Phase Not Applicable
Age: 15Years - 23Years
FEMALE
ID07092332

Young Vulvodynia: Effect and Efficacy of a Multimodal Treatment for Young Women With Vulvar Pain

Led by Region Örebro County · Updated on 2025-07-29

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Region Örebro County

Lead Sponsor

Ö

Örebro University, Sweden

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a multimodal treatment for provoked vulvodynia in young women aged 15 to 23 years. This study uses a sequential single case experimental design with randomized baseline lengths to assess both the effectiveness and patient experiences of the treatment. The goal is to understand how this combined physiological and psychosocial approach impacts vulvar pain and related factors. The treatment includes 11 sessions focusing on goal-directed behavioral changes that address physical and psychological aspects of vulvodynia. These sessions involve various professionals and may include partner participation in two sessions. The intervention covers vulva care, lubrication exercises, pelvic floor relaxation, pain-related thoughts and behaviors, and communication strategies. Participants undergo a baseline period of 4, 5, or 6 weeks with no intervention, followed by 25 weeks of treatment. Participants will complete short self-assessment questionnaires twice weekly during the baseline and treatment periods using the m-Path app. Additional comprehensive web-based questionnaires are completed before treatment, after treatment, and at a six-month follow-up. Researchers will measure genital pain intensity as the primary outcome and assess sexual function, pelvic floor tension, treatment goals, pain coping, mood symptoms, quality of life, and communication as secondary outcomes. The study includes safety monitoring and continued evaluation over time.

CONDITIONS

Brief Title

Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.

Who Can Participate

Age: 15Years - 23Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Biological sex female
  • Age between 15 and 23 years
  • Diagnosed with provoked vulvodynia
Not Eligible

You will not qualify if you...

  • Severe psychological issues requiring priority treatment (e.g., substance abuse, psychosis)
  • Currently pregnant
  • Childbirth within the last year
  • Post-traumatic stress disorder related to sexual trauma
  • Insufficient mastery of the Swedish language
  • No experience of vaginal sex, due to suspected vaginismus requiring different treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Baseline Period

Duration - 4 to 6 weeks

Participants complete a baseline period without intervention during which they respond to a short self-assessment questionnaire twice a week to measure pain and related variables.

Questionnaires twice a week using the m-Path app

Treatment

Duration - Approximately 19 to 21 weeks

Participants receive a multimodal behavioral treatment consisting of 11 sessions addressing physiological and psychosocial aspects of vulvodynia with goal-directed behavior change. Sessions last 60 to 90 minutes each, with the option to involve a partner in two sessions.

11 treatment sessions lasting 60 to 90 minutes each; self-assessments twice a week using the m-Path app

Follow-up

Duration - 6 months after treatment ends

Participants complete a comprehensive web-based self-assessment questionnaire at 6 months after treatment to evaluate longer-term outcomes.

1 follow-up questionnaire (web-based)

Trial Site Locations

Total: 1 location

1

Ungdomsmottagningen

Örebro, Sweden

Actively Recruiting

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Research Team

R

Rebecca Lennartsson, MSc

I

Ida Flink, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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