VulvodyniaEMBLANCT02809612
An Internet-based Information Platform for Vulvodynia Patients
A study testing Internet-based platform in people with Vulvodynia, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvodynia
- What is being tested?
- Internet-based platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study
Who cannot join
- inability to read and understand Swedish
- severe mental illness
- currently in treatment for vulvodynia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vulvodynia
- Being tested
- Internet-based platform
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based platformBehavioural
Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients
| Study group | Role | What they receive |
|---|---|---|
| Internet-based intervention | Experimental | 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. Receives: Behavioral: Internet-based platform |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Unprovoked pain change, post-intervention
Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks)
Measured: Baseline to post-intervention (6 weeks)
Unprovoked pain change, end of clinical treatment
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.
Measured: Baseline to end of clinical treatment (typically 10-12 months) or 1 year following inclusion
Unprovoked pain change, one year post-treatment
Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and 1 year after completion of clinical treatment.
Measured: 1 year after end of clinical treatment
Provoked pain change, post-intervention
Change in self-reported provoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks)
Measured: post-intervention (6 weeks)
Provoked pain change, end of clinical treatment
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.
Measured: after clinical treatment (typically 10-12 months) or 1 year following inclusion
Provoked pain change, one year post-treatment
Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and 1 year after completion of clinical treatment.
Measured: 1 year after ending of clinical treatment
Secondary outcomes (7)
Satisfaction with Life change
Change in satisfaction with Life, assessed with Satisfaction with Life Scale, between baseline and post-intervention (6 weeks)
Measured: Baseline to post-intervention (6 weeks)
Sexuality
Change in sexuality measures, assessed by Female Sexual Function Index (FSFI)
Measured: Baseline to post-intervention (6 weeks)
Number of visits for clinical treatment
Number of visits for clinical treatment
Measured: One year after the end of clinical treatment
Cost-effectiveness, assessed with the EQ-5D scale
Cost-effectiveness, assessed with the EQ-5D scale, from baseline to one year after completion of clinica treatment
Measured: Baseline to one year after completion of clinical treatment
Sexual function parameters
Change in sexual function parameters, assessed by the Female Sexual Dysfunction Scale (SFDS), between baseline and completion of clinical treatment
Measured: Baseline to end of clinical treatment
Number of days off work
Measured: Baseline to end of clinical treatment
Satisfaction with Life change, 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
Measured: Baseline to one year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMar 2016
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alkistis Skalkidou, MD, PhD, Principal investigator, Dept of Women's and Children's Health, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809612
- Sponsor's protocol ID
- EMBLA
- Acronym
- EMBLA
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2016
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Haefner HK. Report of the International Society for the Study of Vulvovaginal Disease terminology and classification of vulvodynia. J Low Genit Tract Dis. 2007 Jan;11(1):48-9. doi: 10.1097/01.lgt.0000225898.37090.04. No abstract available.
PubMed 17194952Arnold LD, Bachmann GA, Rosen R, Rhoads GG. Assessment of vulvodynia symptoms in a sample of US women: a prevalence survey with a nested case control study. Am J Obstet Gynecol. 2007 Feb;196(2):128.e1-6. doi: 10.1016/j.ajog.2006.07.047.
PubMed 17306651Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8.
PubMed 12744420Haefner HK, Collins ME, Davis GD, Edwards L, Foster DC, Hartmann ED, Kaufman RH, Lynch PJ, Margesson LJ, Moyal-Barracco M, Piper CK, Reed BD, Stewart EG, Wilkinson EJ. The vulvodynia guideline. J Low Genit Tract Dis. 2005 Jan;9(1):40-51. doi: 10.1097/00128360-200501000-00009.
PubMed 15870521Amstadter AB, Broman-Fulks J, Zinzow H, Ruggiero KJ, Cercone J. Internet-based interventions for traumatic stress-related mental health problems: a review and suggestion for future research. Clin Psychol Rev. 2009 Jul;29(5):410-20. doi: 10.1016/j.cpr.2009.04.001. Epub 2009 Apr 7.
PubMed 19403215Tursi MF, Baes Cv, Camacho FR, Tofoli SM, Juruena MF. Effectiveness of psychoeducation for depression: a systematic review. Aust N Z J Psychiatry. 2013 Nov;47(11):1019-31. doi: 10.1177/0004867413491154. Epub 2013 Jun 5.
PubMed 23739312Backman H, Widenbrant M, Bohm-Starke N, Dahlof LG. Combined physical and psychosexual therapy for provoked vestibulodynia-an evaluation of a multidisciplinary treatment model. J Sex Res. 2008 Oct-Dec;45(4):378-85. doi: 10.1080/00224490802398365.
PubMed 18937129Bohm-Starke N. Medical and physical predictors of localized provoked vulvodynia. Acta Obstet Gynecol Scand. 2010 Dec;89(12):1504-10. doi: 10.3109/00016349.2010.528368.
PubMed 21080898Heddini U, Bohm-Starke N, Nilsson KW, Johannesson U. Provoked vestibulodynia--medical factors and comorbidity associated with treatment outcome. J Sex Med. 2012 May;9(5):1400-6. doi: 10.1111/j.1743-6109.2012.02665.x. Epub 2012 Feb 29.
PubMed 22376009Desrochers G, Bergeron S, Khalife S, Dupuis MJ, Jodoin M. Provoked vestibulodynia: psychological predictors of topical and cognitive-behavioral treatment outcome. Behav Res Ther. 2010 Feb;48(2):106-15. doi: 10.1016/j.brat.2009.09.014. Epub 2009 Oct 7.
PubMed 19879555Wijma B, Wijma K. A Cognitive Behavioral Treatment Model of Vaginismus. Scand J Behav Ther 1997;26:147-156.
Palm A, Danielsson I. SFOGs ARG-rapport för tonårsgynekologi. Sexuell och reproduktiv hälsa hos ungdomar 2013:73-76.
Chapple CR, Zimmern PE, Brubaker L, Smith ARB, Bo K. Multidisciplinary Management of Female Pelvic Floor Disorders. Philadelphia: Churchill Livingstone Elsevier; 2006.
Hess Engstrom AH, Kullinger M, Jawad I, Hesselman S, Buhrman M, Hogberg U, Skalkidou A. Internet-based treatment for vulvodynia (EMBLA) - Study protocol for a randomised controlled study. Internet Interv. 2021 Apr 20;25:100396. doi: 10.1016/j.invent.2021.100396. eCollection 2021 Sep.
PubMed 33996511
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients
- ClinicalTrials.gov ID
- NCT02809612
- Acronym / sponsor ID
- EMBLA / EMBLA
- Conditions
- Vulvodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based intervention | Experimental | Behavioral: Internet-based platformPatients 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. |
| Control group | No intervention | –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). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study
Key exclusion criteria (3 listed)
- inability to read and understand Swedish
- severe mental illness
- currently in treatment for vulvodynia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based platformInternet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients | Behavioural | Internet-based intervention |
Primary outcome
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)
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.
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.
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)
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.
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.
7 secondary outcomes
Satisfaction with Life change
Time frame: Baseline to post-intervention (6 weeks)
Sexuality
Time frame: Baseline to post-intervention (6 weeks)
Number of visits for clinical treatment
Time frame: 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
Sexual function parameters
Time frame: Baseline to end of clinical treatment
Number of days off work
Time frame: Baseline to end of clinical treatment
Satisfaction with Life change, one year post-treatment
Time frame: Baseline to one year post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 17194952Haefner HK. Report of the International Society for the Study of Vulvovaginal Disease terminology and classification of vulvodynia. J Low Genit Tract Dis. 2007 Jan;11(1):48-9. doi: 10.1097/01.lgt.0000225898.37090.04. No abstract available.
- Background: PubMed 17306651Arnold LD, Bachmann GA, Rosen R, Rhoads GG. Assessment of vulvodynia symptoms in a sample of US women: a prevalence survey with a nested case control study. Am J Obstet Gynecol. 2007 Feb;196(2):128.e1-6. doi: 10.1016/j.ajog.2006.07.047.
- Background: PubMed 12744420Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8.
- Background: PubMed 15870521Haefner HK, Collins ME, Davis GD, Edwards L, Foster DC, Hartmann ED, Kaufman RH, Lynch PJ, Margesson LJ, Moyal-Barracco M, Piper CK, Reed BD, Stewart EG, Wilkinson EJ. The vulvodynia guideline. J Low Genit Tract Dis. 2005 Jan;9(1):40-51. doi: 10.1097/00128360-200501000-00009.
- Background: PubMed 19403215Amstadter AB, Broman-Fulks J, Zinzow H, Ruggiero KJ, Cercone J. Internet-based interventions for traumatic stress-related mental health problems: a review and suggestion for future research. Clin Psychol Rev. 2009 Jul;29(5):410-20. doi: 10.1016/j.cpr.2009.04.001. Epub 2009 Apr 7.
- Background: PubMed 23739312Tursi MF, Baes Cv, Camacho FR, Tofoli SM, Juruena MF. Effectiveness of psychoeducation for depression: a systematic review. Aust N Z J Psychiatry. 2013 Nov;47(11):1019-31. doi: 10.1177/0004867413491154. Epub 2013 Jun 5.
- Background: PubMed 18937129Backman H, Widenbrant M, Bohm-Starke N, Dahlof LG. Combined physical and psychosexual therapy for provoked vestibulodynia-an evaluation of a multidisciplinary treatment model. J Sex Res. 2008 Oct-Dec;45(4):378-85. doi: 10.1080/00224490802398365.
- Background: PubMed 21080898Bohm-Starke N. Medical and physical predictors of localized provoked vulvodynia. Acta Obstet Gynecol Scand. 2010 Dec;89(12):1504-10. doi: 10.3109/00016349.2010.528368.
- Background: PubMed 22376009Heddini U, Bohm-Starke N, Nilsson KW, Johannesson U. Provoked vestibulodynia--medical factors and comorbidity associated with treatment outcome. J Sex Med. 2012 May;9(5):1400-6. doi: 10.1111/j.1743-6109.2012.02665.x. Epub 2012 Feb 29.
- Background: PubMed 19879555Desrochers G, Bergeron S, Khalife S, Dupuis MJ, Jodoin M. Provoked vestibulodynia: psychological predictors of topical and cognitive-behavioral treatment outcome. Behav Res Ther. 2010 Feb;48(2):106-15. doi: 10.1016/j.brat.2009.09.014. Epub 2009 Oct 7.
- BackgroundWijma B, Wijma K. A Cognitive Behavioral Treatment Model of Vaginismus. Scand J Behav Ther 1997;26:147-156.
- BackgroundPalm A, Danielsson I. SFOGs ARG-rapport för tonårsgynekologi. Sexuell och reproduktiv hälsa hos ungdomar 2013:73-76.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alkistis Skalkidou, MD, PhD principal investigator
Dept of Women's and Children's Health, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based platform in people with Vulvodynia, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unprovoked pain change, post-intervention (time frame: Baseline to post-intervention (6 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809612, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.