Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Biological sex female
- Age between 15 and 23 years
- Diagnosed with provoked vulvodynia
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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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
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
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
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
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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