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Completed

NCT Number: NCT02809612

An Internet-based Information Platform for Vulvodynia Patients

Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological condition that leads to extreme suffering for both the women involved but also their partners. It has also been shown to be associated with poor quality of life, leading to depression and anxiety states. When left untreated, the condition takes a very long time to resolve, with a substantial associated disability and suffering. Both psycho-education and internet-based interventions have been shown to be highly successful while they can be quite affordable. This makes them highly cost-effective. The present study aims at evaluating the effectiveness of such an intervention among a vulvodynia patient population from the clinics of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians and given access to the internet-based platform, where they will fill out questionnaires during four different time-points, after randomization to the control or the intervention group. The intervention group will also have access to multiple activities and information material uploaded in the internet-based platform. Differences in pain, quality of life and mental health parameter outcomes will be assessed at the end of the study. Should this intervention prove effective, it will be implemented in clinical praxis in the four regions.

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Key information

Conditions

Vulvodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gynecological Department, Akademiska Hospital

Uppsala, 75185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study

Exclusion criteria

  • inability to read and understand Swedish
  • severe mental illness
  • currently in treatment for vulvodynia

Treatment and study plan

Internet-based platform

Behavioral

Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients

Primary outcomes

  1. Unprovoked pain change, post-intervention

    Time frame: Baseline to post-intervention (6 weeks)

    Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks)

  2. Unprovoked pain change, end of clinical treatment

    Time frame: Baseline to end of clinical treatment (typically 10-12 months) or 1 year following inclusion

    Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and after completion of clinical treatment or 1 year following inclusion.

  3. Unprovoked pain change, one year post-treatment

    Time frame: 1 year after end of clinical treatment

    Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and 1 year after completion of clinical treatment.

  4. Provoked pain change, post-intervention

    Time frame: post-intervention (6 weeks)

    Change in self-reported provoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks)

  5. Provoked pain change, end of clinical treatment

    Time frame: after clinical treatment (typically 10-12 months) or 1 year following inclusion

    Change in self-reported provoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and after completion of clinical treatment or 1 year following inclusion.

  6. Provoked pain change, one year post-treatment

    Time frame: 1 year after ending of clinical treatment

    Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and 1 year after completion of clinical treatment.

Secondary outcomes

  1. Satisfaction with Life change

    Time frame: Baseline to post-intervention (6 weeks)

    Change in satisfaction with Life, assessed with Satisfaction with Life Scale, between baseline and post-intervention (6 weeks)

  2. Sexuality

    Time frame: Baseline to post-intervention (6 weeks)

    Change in sexuality measures, assessed by Female Sexual Function Index (FSFI)

  3. Number of visits for clinical treatment

    Time frame: One year after the end of clinical treatment

    Number of visits for clinical treatment

  4. Cost-effectiveness, assessed with the EQ-5D scale

    Time frame: Baseline to one year after completion of clinical treatment

    Cost-effectiveness, assessed with the EQ-5D scale, from baseline to one year after completion of clinica treatment

  5. Sexual function parameters

    Time frame: Baseline to end of clinical treatment

    Change in sexual function parameters, assessed by the Female Sexual Dysfunction Scale (SFDS), between baseline and completion of clinical treatment

  6. Number of days off work

    Time frame: Baseline to end of clinical treatment

  7. Satisfaction with Life change, one year post-treatment

    Time frame: Baseline to one year post-treatment

    Change in satisfaction with Life, assessed with Satisfaction with Life Scale, between baseline and one year after completion of clinical treatment

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients

Acronym: EMBLA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2016
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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