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Идёт набор NCT07092332

Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.

Без фазы С лечением Vulvodynia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Multimodal treatment.
Кому может быть актуально
Состояния в реестре: Vulvodynia. Базовые параметры: 15 лет — 23 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Genital Pain Intensity [Срок оценки: 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.]
Вторичные конечные точки (10)
  • Sexual Function [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
  • Sexual Pain Coping [Срок оценки: 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 [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]
  • Depressive symptoms [Срок оценки: Pre and post treatment, and at 6 months follow-up]
  • Anxiety symptoms [Срок оценки: Pre- and post treatment and at 6 month follow-up.]
  • Change in quality of life [Срок оценки: Pre and post treatment, and at 6 months follow-up]
  • Change in life interference, sexual function interference and communication. [Срок оценки: Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up]

Критерии участия

Критерии включения

  • Biological sex female
  • 15-23 years of age
  • Diagnosed with Provoked vulvodynia

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Швеция · 1 центр
  • Ungdomsmottagningen — Örebro

Идентификаторы

NCT: NCT07092332 · 282171 · RFR-1010966 · OLL-1013529

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗