Vulvodynia Intervention: the Effect of Multimodal Treatment for Provoked Vulvodynia

NCT06981611 | Recruiting

• 2 other identifiers: 2024-03946-012023-00377
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

• 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

Conditions

Vulvodynia (Chronic Vulvar Pain)

Keywords

Vulvodynia; Provoked vulvodynia; multimodal treatment; cognitive behavioral therapy; cbt; couple treatment; single-case experimental design; sced; chronic pain; Vulvodynia Intervention

Outcome Measures

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.

  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 (10)

• Change in sexual function

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

• Change in treatment goal attainment

  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.

• Change in pelvic floor tension

  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.

• Change in sexual satisfaction

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

• Change in interpersonal and self focused sexual goals

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

Other Outcomes (11)

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

  during treatment period

• Demographic

  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.

• Change in sexual desire and arousal

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

Study Arms (2)

Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia

EXPERIMENTAL

A multimodal treatment consisting of approximately 11 treatment sessions, for provoked vulvodynia. Working with goal-directed behavior change that has both physiological and psychosocial components. The treatment sessions will be conducted with various professionals, via digital video meetings and meetings at the health care facilities. The first five sessions are conducted weekly, and the last six sessions are conducted biweekly. A follow-up session is conducted three months after the end of the treatment. Repeated measurements (twice a week) are being collected throughout this period.

Behavioral: Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia

Randomized to waiting period of 4, 5 or 6 weeks

NO INTERVENTION

Participants are randomized to a 4, 5 or 6 week waiting period/baseline. Repeated measurements (twice a week) are being collected throughout this period.

Interventions

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.

Vulvodynia Intervention: a multimodal treatment for provoked vulvodynia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Biological sex: Female 18-40 years old Provoked vulvodynia

You may not qualify if:

• 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

Sponsors & Collaborators

• Karlstad University: lead
• Region Stockholm: collaborator
• Region Örebro County: collaborator
• Region Jönköping County: collaborator
• Region Värmland: collaborator

Study Sites (1)

Karlstad University

Karlstad, Sweden

RECRUITING

MeSH Terms

Conditions

Vulvodynia; Color Vision Defects; Chronic Pain

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to baseline length allocations.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in psychology

Model Details: The study utilizes a sequential single-case experimental AB design with randomized waiting period length (4, 5 or 6 weeks). Included in the design is also a pre-, post- and 6 month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from patients, to explore experiences of participation in the study and the treatment.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: May 21, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)