An Internet-based Information Platform for Vulvodynia Patients

NCT02809612 | Completed

• 1 other identifier: EMBLA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvodynia

Outcome Measures

Primary Outcomes (6)

• 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)

• 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

• 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

• 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)

• 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

• 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 Outcomes (7)

• Satisfaction with Life change

  Baseline to post-intervention (6 weeks)

• Sexuality

  Baseline to post-intervention (6 weeks)

• Number of visits for clinical treatment

  One year after the end of clinical treatment

• Cost-effectiveness, assessed with the EQ-5D scale

  Baseline to one year after completion of clinical treatment

• Sexual function parameters

  Baseline to end of clinical treatment

Study Arms (2)

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.

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).

Interventions

Internet-based platform BEHAVIORAL

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

Internet-based intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study

You may not qualify if:

• inability to read and understand Swedish
• severe mental illness
• currently in treatment for vulvodynia

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Gynecological Department, Akademiska Hospital

Uppsala, 75185, Sweden

Location

Related Publications (14)

• 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.

  PMID: 17194952 BACKGROUND

• 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. doi: 10.1016/j.ajog.2006.07.047.

  PMID: 17306651 BACKGROUND

• 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.

  PMID: 12744420 BACKGROUND

• 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. doi: 10.1097/00128360-200501000-00009.

  PMID: 15870521 BACKGROUND

• 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.

  PMID: 19403215 BACKGROUND

• 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.

  PMID: 23739312 BACKGROUND

• 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.

  PMID: 18937129 BACKGROUND

• 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.

  PMID: 21080898 BACKGROUND

• 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.

  PMID: 22376009 BACKGROUND

• Desrochers 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.

  PMID: 19879555 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 33996511 DERIVED

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Alkistis Skalkidou, MD, PhD

  Dept of Women's and Children's Health, Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: June 22, 2016
• Study Start: March 1, 2016
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)