Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal treatment.
- Who it may be relevant to
- Registry conditions: Vulvodynia. Basic parameters: 15 years — 23 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Young Vulvodynia: Effect and Efficacy of a Multimodal Treatment for Young Women With Vulvar Pain
Overview
The aim of this SCED-study is to evaluate a multimodal treatment for vulvodynia in young women. The main questions it aims to answer are: 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.
Detailed description
The current study is an effectiveness evaluation, applying a sequential single case experimental AB design (SCED) with randomized baseline length, implemented at a youth guidance center. Potential participants will be informed about the study and answer a few questions digitally to ensure that participation in the study is appropriate for them. An assessment will then be conducted and questions will be asked about the pain, psychological, sexual and relational health, and a diagnostic interview will be conducted to exclude other psychological issues that needs to be prioritized before vulvodynia treatment.
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.
Interventions
- Behavioral 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 educa
Primary outcome measures
- Genital Pain Intensity [Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.]
Secondary outcome measures (10)
- Sexual Function [Time frame: FSFI: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. FSFI-6 Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.]
- Participant Identified Treatment Goal [Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.]
- Pelvic Floor Tension [Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at a 6 month follow-up. During baseline and treatment period measured twice a week, for 25 weeks.]
- Sexual Satisfaction [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
- Sexual Pain Coping [Time frame: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 weeks´.]
- Pain Catastrophizing [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
- Depressive symptoms [Time frame: Pre and post treatment, and at 6 months follow-up]
- Anxiety symptoms [Time frame: Pre- and post treatment and at 6 month follow-up.]
- Change in quality of life [Time frame: Pre and post treatment, and at 6 months follow-up]
- Change in life interference, sexual function interference and communication. [Time frame: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
Eligibility criteria
Inclusion criteria
- Biological sex female
- 15-23 years of age
- Diagnosed with 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Ungdomsmottagningen — Örebro
Identifiers
NCT: NCT07092332 · 282171 · RFR-1010966 · OLL-1013529