Young Vulvodynia: Effect and Efficacy of Multimodal Treatment. (UV)

Region Örebro County

Status

Enrolling

Conditions

Vulvodynia

Treatments

Behavioral: Multimodal treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT07092332

282171

RFR-1010966 (Other Grant/Funding Number)

OLL-1013529 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

Female

Ages

15 to 23 years old

Volunteers

No Healthy Volunteers

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