Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.
NCT ID: NCT07092332
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-06-10
2026-12-31
Brief Summary
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Is multimodal treatment effective for provoked vulvodynia in young women? How is multimodal treatment experienced by young women with vulvodynia?
Participants will respond to frequent questionnaires (two times a week) during a baseline period of 4,5 or 6 weeks, as well as during their treatment period ( a total of 25 weeks). In addition they will respond to pre-, post-treatment and 6 month follow-up questionnaires.
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Detailed Description
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After the assessment interview and inclusion, participants will be randomized in tiers to a 4, 5, or 6 week baseline period. Thereafter, the treatment will begin. During the baseline and treatment period, participants will complete a short self-assessment questionnaire, twice a week, to measure pain (primary outcome) and other key variables. To facilitate the repeated assessments, we will use the m-Path app, which was developed by KU Leuven University in Belgium to easily evaluate treatment for both patients and therapists. In addition to the repeated assessments, the treatment will be evaluated through a comprehensive web-based self-assessment questionnaire before and after the intervention and at a six-month follow-up. The outcome measures are in line with Core Outcome set in Vulvodynia.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Baseline period
During a 4, 5 or 6 week waiting period, participants respond to a short questionnaire twice a week.
No interventions assigned to this group
Multimodal Treatment
Multimodal Treatment.
Multimodal treatment
Vulvodynia Intervention adapted for late adolescents and young adults. A multimodal treatment for provoked vulvodynia
The treatment consists of 11 treatment sessions. Working with goal-directed behavior change that has both physiological and psychosocial components. The treatment sessions will be conducted with various professionals, bot simultaneously and separately.
The intervention is based on physiological and psychosocial components working with goal-directed behavioral change; both educational and practical elements, examples of these are vulva care, lubrication exercises, pelvic floor relaxation, work with thoughts, feelings, and behaviors related to the pain, as well as thoughts, feelings and behaviors related to sex and desire, and educational and practical elements focusing on open communication and validation. The treatment sessions are between 60 to 90 minutes each. There is a possibility for the participants to involve partner during two of the treatment sessions.
Interventions
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Multimodal treatment
Vulvodynia Intervention adapted for late adolescents and young adults. A multimodal treatment for provoked vulvodynia
The treatment consists of 11 treatment sessions. Working with goal-directed behavior change that has both physiological and psychosocial components. The treatment sessions will be conducted with various professionals, bot simultaneously and separately.
The intervention is based on physiological and psychosocial components working with goal-directed behavioral change; both educational and practical elements, examples of these are vulva care, lubrication exercises, pelvic floor relaxation, work with thoughts, feelings, and behaviors related to the pain, as well as thoughts, feelings and behaviors related to sex and desire, and educational and practical elements focusing on open communication and validation. The treatment sessions are between 60 to 90 minutes each. There is a possibility for the participants to involve partner during two of the treatment sessions.
Eligibility Criteria
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Inclusion Criteria
* 15-23 years of age
* Diagnosed with Provoked vulvodynia
Exclusion Criteria
* 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
15 Years
23 Years
FEMALE
No
Sponsors
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Örebro University, Sweden
OTHER
Region Örebro County
OTHER
Responsible Party
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Rebecca Lennartsson
Doctoral Student
Locations
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Ungdomsmottagningen
Örebro, , Sweden
Countries
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Central Contacts
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Other Identifiers
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RFR-1010966
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
OLL-1013529
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
282171
Identifier Type: -
Identifier Source: org_study_id
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