Vulvodynia
Conditions
Brief summary
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.
Interventions
BEHAVIORALInternet-based platform
Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unprovoked pain change, post-intervention | 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) |
| Unprovoked pain change, end of clinical treatment | 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. |
| Unprovoked pain change, one year post-treatment | 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. |
| Provoked pain change, post-intervention | post-intervention (6 weeks) | Change in self-reported provoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks) |
| Provoked pain change, end of clinical treatment | 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. |
| Provoked pain change, one year post-treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Sexual function parameters | 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 |
| Satisfaction with Life change, one year post-treatment | 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 |
| Number of days off work | Baseline to end of clinical treatment | — |
| Satisfaction with Life change | Baseline to post-intervention (6 weeks) | Change in satisfaction with Life, assessed with Satisfaction with Life Scale, between baseline and post-intervention (6 weeks) |
| Sexuality | Baseline to post-intervention (6 weeks) | Change in sexuality measures, assessed by Female Sexual Function Index (FSFI) |
| Number of visits for clinical treatment | One year after the end of clinical treatment | Number of visits for clinical treatment |
| Cost-effectiveness, assessed with the EQ-5D scale | 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 |
Countries
Sweden
Outcome results
None listed