An Internet-based Information Platform for Vulvodynia Patients

Vulvodynia Clinical Trial

— EMBLA  

Official title:

The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809612
• Other study ID #: EMBLA
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2021
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Vulvodynia

Intervention

Behavioral:
• Internet-based platform
Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients

Locations

Country	Name	City	State
Sweden	Gynecological Department, Akademiska Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (13)

Amstadter 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. Review. — View Citation

Arnold 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. — View Citation

Backman 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. — View Citation

Bohm-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. Review. — View Citation

Chapple CR, Zimmern PE, Brubaker L, Smith ARB, Bo K. Multidisciplinary Management of Female Pelvic Floor Disorders. Philadelphia: Churchill Livingstone Elsevier; 2006.

Desrochers G, Bergeron S, Khalifé 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. — View Citation

Haefner 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. Review. — View Citation

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. — View Citation

Harlow 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. — View Citation

Heddini 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. — View Citation

Palm A, Danielsson I. SFOGs ARG-rapport för tonårsgynekologi. Sexuell och reproduktiv hälsa hos ungdomar 2013:73-76.

Tursi 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. Review. — View Citation

Wijma B, Wijma K. A Cognitive Behavioral Treatment Model of Vaginismus. Scand J Behav Ther 1997;26:147-156.

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline to post-intervention (6 weeks)
Primary	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.	Baseline to end of clinical treatment (typically 10-12 months) or 1 year following inclusion
Primary	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.	1 year after end of clinical treatment
Primary	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)	post-intervention (6 weeks)
Primary	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.	after clinical treatment (typically 10-12 months) or 1 year following inclusion
Primary	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.	1 year after ending of clinical treatment
Secondary	Satisfaction with Life change	Change in satisfaction with Life, assessed with Satisfaction with Life Scale, between baseline and post-intervention (6 weeks)	Baseline to post-intervention (6 weeks)
Secondary	Sexuality	Change in sexuality measures, assessed by Female Sexual Function Index (FSFI)	Baseline to post-intervention (6 weeks)
Secondary	Number of visits for clinical treatment	Number of visits for clinical treatment	One year after the end of clinical treatment
Secondary	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	Baseline to one year after completion of clinical treatment
Secondary	Sexual function parameters	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
Secondary	Number of days off work		Baseline to end of clinical treatment
Secondary	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	Baseline to one year post-treatment