Health TrialsbyHealthPanel

Young Vulvodynia: Effect and Efficacy of Multimodal Treatment.

ConditionVulvodynia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-23
SponsorRegion Örebro County

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biological sex female

15-23 years of age

Diagnosed with Provoked vulvodynia

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Multimodal treatment

    Behavioral

    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.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Baseline periodNo intervention 0 interventions
Group B: Multimodal TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Genital Pain Intensity

Provoked pain during sexual and non-sexual activities. Seven activities where pain is rated on a scale from 0 to 10. Higher scoring indicates higher degree of pain. There are also subsequent questions regarding whether they have performed the described activity or not within a specific time frame.

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 outcomes

1

Sexual Function

The Female Sexual Function Index (FSFI) is a self-report measure of female sexual function that assesses six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. It consists of 19 questions, rated on a 5-point scale, with a higher score indicating a better sexual function. The short version, FSFI-6 contains 6 questions.

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.
2

Participant Identified Treatment Goal

All participants identify one own primary goal. Participants chose an individual treatment goal and rate treatment goal attainment, from 0-10, 0= the goal is not at all achieved, 10= the goal is achieved.

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.
3

Pelvic Floor Tension

Self-report assessment of pelvic floor tension and pelvic floor relaxation. Two items rated on a 11-point scale, from 0-10, higher scores indicate greater tension and more difficulty relaxing the pelvic floor, and physiotherapeutic examination.

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.
4

Sexual Satisfaction

Sexual Satisfaction as measured with Global Measure of Sexual Satisfaction (GMSEX), 5 items rated on a 7 point scale. Higher scores indicate a higher degree of sexual function.

Time frame
Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up

Other outcomes

1

Demographic

Age, country of birth, educational level, occupation, if they have a partner/-s, how long they have been in that relationship/-s, gender of partner/-s, if they have kids, childbirth during the last year, ongoing pregnancy, menstruation

Time frame
Pre treatment. Questions about partner/-s are measured pre and post treatment and at 6 month follow-up.
2

Experiences of sexual and physical abuse

Using the Sexual and Physical Abuse Questionnaire (SPAQ).

Time frame
Pre-treatment
3

Treatment expectations

2 items rated on a 11-point scale, from 0 to 10. Higher scoring indicating higher expectations that this treatment will be helpful.

Time frame
Pre-treatment
4

Negative treatment effects

1-2 items measuring negative effects of the treatment. One questions that asks if the participant experienced any negative effects of the treatment, with a following question asking the participant to describe more in an open answer.

Time frame
Post-treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Örebro County

Lead sponsor

Örebro University, Sweden

Collaborator

Source ClinicalTrials.gov
Apply now