An Internet-based Information Platform for Vulvodynia Patients (EMBLA)

Uppsala University

Status: Completed

Conditions: Vulvodynia

Treatments: Behavioral: Internet-based platform

Study type: Interventional

Funder types: Other

Identifiers

NCT02809612

EMBLA

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Internet-based intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-based platform

Control group

No Intervention group

Description:

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).