An Internet-based Information Platform for Vulvodynia Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Vulvodynia

Intervention / Treatment
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* Behavioral: Internet-based platform


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based intervention<br>Patients randomized to the internet-based intervention will be given access to the information in the internet-based platform directly after randomization. During the first 6 weeks, information will be offered in a structured way, with a theme changing weekly. After this time-point, the patients will have the possibility to navigate through all information. The platform encompasses internet-based training including information on the disorder, psycho-education and information of simple self-implemented intervention strategies cope with vulvodynia and ameliorate dyspareunia. The platform will also include videos where team members will describe their role in treating patients with the disorder, but also short videos from former patients willing to share their individual stories. | Behavioral: Internet-based platform<br>* Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients<br>|
| No Intervention: Control group<br>Patients randomized to the control group through the platform will immediately be informed about the fact that there is available information and resources on the internet and that they will be called for a visit to the physiotherapist-midwife at due time, according to the present guidelines of care followed in the respective clinic (Uppsala, Falun, Gävle). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unprovoked pain change, post-intervention | Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks) | Baseline to post-intervention (6 weeks) | 
| Unprovoked pain change, end of clinical treatment | 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. | Baseline to end of clinical treatment (typically 10-12 months) or 1 year following inclusion | 
| Unprovoked pain change, one year post-treatment | Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and 1 year after completion of clinical treatment. | 1 year after end of clinical treatment | 
| Provoked pain change, post-intervention | Change in self-reported provoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks) | post-intervention (6 weeks) | 
| Provoked pain change, end of clinical treatment | 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. | after clinical treatment (typically 10-12 months) or 1 year following inclusion | 
| Provoked pain change, one year post-treatment | Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and 1 year after completion of clinical treatment. | 1 year after ending of clinical treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Life change | Change in satisfaction with Life, assessed with Satisfaction with Life Scale, between baseline and post-intervention (6 weeks) | Baseline to post-intervention (6 weeks) | 
| Sexuality | Change in sexuality measures, assessed by Female Sexual Function Index (FSFI) | Baseline to post-intervention (6 weeks) | 
| Number of visits for clinical treatment | Number of visits for clinical treatment | One year after the end of clinical treatment | 
| Cost-effectiveness, assessed with the EQ-5D scale | Cost-effectiveness, assessed with the EQ-5D scale, from baseline to one year after completion of clinica treatment | Baseline to one year after completion of clinical treatment | 
| Sexual function parameters | Change in sexual function parameters, assessed by the Female Sexual Dysfunction Scale (SFDS), between baseline and completion of clinical treatment | Baseline to end of clinical treatment | 
| Number of days off work |  | Baseline to end of clinical treatment | 
| Satisfaction with Life change, 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 | Baseline to one year post-treatment |