Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorKarlstad University

About this trial

The purpose of this project is to develop and evaluate a multimodal treatment for provoked vulvodynia, by addressing the following specific research questions:

1. What is the feasibility and acceptability of this multimodal treatment protocol? 2. What are the effects on pain and psychosexual health? 3. How is the treatment perceived by patients, clinicians and stakeholders in the health care setting, and how do they view the possibilities for implementation?

Participants will be recruited through their health care unit and receive a multimodal treatment. The treatment consists of individual sessions with different professionals, in total 11 sessions over a time period of four months. It is possible to involve partners in the treatment during two of the treatment sessions. The majority of the sessions are digital video meetings but some are conducted at the health care unit. The treatment are based on physiological and psychosocial components that have previously shown positive effects for individuals with vulvodynia, and includes both educational and practical elements.

The participants will:

* Undergo a gynecological examination and a psychological assessment to determine if the treatment is suitable for their condition * Undergo a multimodal treatment * Complete questionnaires regarding their pain, physical tension, psychosexual and relational health and questions about the treatment * Be asked to participate in an interview about their experience of the treatment and intimacy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

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

  • Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia

    Behavioral

    The intervention is based around physiological and psychosocial components working with goal-directed behavioral change. Includes 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 approximately 60 minutes each. There is a possibility for the participants to involve partner during two of the treatment sessions.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Vulvodynia Intervention: a multimodal treatment for provoked vulvodyniaExperimental treatment 1 intervention
Group B: Randomized to waiting period of 4, 5 or 6 weeksNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in pain during touch and/or insertion of an object

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, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 weeks.

Secondary outcomes

1

Change in 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.

Time frame
Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up
2

Change in treatment goal attainment

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

Change in 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

Change in sexual satisfaction

Global measure of sexual satisfaction (GMSEX), 5 items rated on a 7-point scale. Higher scores indicate a higher degree of sexual satisfaction.

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

Other outcomes

1

Evaluation of how much time participants spend on the treatment and related exercises

Time frame
during treatment period
2

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 (25 weeks after the baseline measurement started). Questions about partner/-s are measured pre and post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up.
3

Change in sexual desire and arousal

Two items from the female sexual function index, measuring sexual desire and arousal, rated on a 5-point scale. Higher scoring indicate greater sexual desire and arousal.

Time frame
Repeated measure twice a week during baseline and treatment period, for 25 weeks.
4

Change in pain catastrophizing

Pain catastrophizing scale (PCS) evaluates participants negative cognitive and emotional reactions to pain. It assesses the extent of catastrophic thinking due to pain according to three subscales: rumination, magnification and helplessness. 13 items rated on a 5-point scale from 0 (not at all) to 4 (all the time). Higher scores indicating greater levels of pain catastrophizing.

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

Sponsors and contacts

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

Karlstad University

Lead sponsor

Region Stockholm

Collaborator

Region Örebro County

Collaborator

Region Jönköping County

Collaborator

Region Värmland

Collaborator