Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-18 @ 6:05 PM
Study NCT ID:
NCT02809612
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Internet-based Information Platform for Vulvodynia Patients
Sponsor:
Uppsala University
Organization:
Study Overview
Official Title:
The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMBLA
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: