Clinical trial NCT02809612: An Internet-based Information Platform for Vulvodynia Patients
Official title: The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvodynia
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 52
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Unprovoked pain change, post-intervention
timeFrame: Baseline to post-intervention (6 weeks)
measure: Unprovoked pain change, end of clinical treatment
timeFrame: Baseline to end of clinical treatment (typically 10-12 months) or 1 year following inclusion
measure: Unprovoked pain change, one year post-treatment
timeFrame: 1 year after end of clinical treatment
measure: Provoked pain change, post-intervention
timeFrame: post-intervention (6 weeks)
measure: Provoked pain change, end of clinical treatment
timeFrame: after clinical treatment (typically 10-12 months) or 1 year following inclusion
measure: Provoked pain change, one year post-treatment
timeFrame: 1 year after ending of clinical treatment
Secondary outcomes:
measure: Satisfaction with Life change
timeFrame: Baseline to post-intervention (6 weeks)
measure: Sexuality
timeFrame: Baseline to post-intervention (6 weeks)
measure: Number of visits for clinical treatment
timeFrame: One year after the end of clinical treatment
measure: Cost-effectiveness, assessed with the EQ-5D scale
timeFrame: Baseline to one year after completion of clinical treatment
measure: Sexual function parameters
timeFrame: Baseline to end of clinical treatment
measure: Number of days off work
timeFrame: Baseline to end of clinical treatment
measure: Satisfaction with Life change, one year post-treatment
timeFrame: Baseline to one year post-treatment
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Gynecological Department, Akademiska Hospital
Study officials:
affiliation: Dept of Women's and Children's Health, Uppsala University
name: Alkistis Skalkidou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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