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

April 27, 2021 updated by: Uppsala University

The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Gynecological Department, Akademiska Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Internet-based intervention
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
Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients
NO_INTERVENTION: Control group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline to post-intervention (6 weeks)
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.
Baseline to end of clinical treatment (typically 10-12 months) or 1 year following inclusion
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.
1 year after end of clinical treatment
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)
post-intervention (6 weeks)
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.
after clinical treatment (typically 10-12 months) or 1 year following inclusion
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.
1 year after ending of clinical treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline to post-intervention (6 weeks)
Sexuality
Time Frame: Baseline to post-intervention (6 weeks)
Change in sexuality measures, assessed by Female Sexual Function Index (FSFI)
Baseline to post-intervention (6 weeks)
Number of visits for clinical treatment
Time Frame: One year after the end of clinical treatment
Number of visits for clinical treatment
One year after the end of clinical treatment
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
Baseline to one year after completion of clinical treatment
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
Baseline to end of clinical treatment
Number of days off work
Time Frame: Baseline to end of clinical treatment
Baseline to end of clinical treatment
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
Baseline to one year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Alkistis Skalkidou, MD, PhD, Dept of Women's and Children's Health, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (ESTIMATE)

June 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMBLA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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