Background & Aims
About 7-15 % of women in Western countries suffer from chronic vulvovaginal pain, i.e. vulvodynia, with provoked localized vulvodynia (PVD) being the most common form. Vulvodynia has detrimental effects on sexual, emotional and relational health. Despite that, effective treatments are few. In particular, multimodal interventions are lacking. Yet, recent clinical guidelines recommend multimodal interventions but conclude that more research on the effect is needed (1). The aim of the current project was to develop a multimodal treatment for women with PVD, and to test its feasibility, acceptability, and preliminary effects with an aggregated single case experimental design (SCED). In this study protocol, we present the included sub-studies, as well as the multimodal treatment model.
Methods
The project applies a user-oriented approach, involving patients, clinicians and stakeholders in the health care organization. The multimodal treatment is centered around behavioral change, based on two theoretical models: a biopsychosocial model, and the fear-avoidance model of vulvodynia. It consists of a range of 10-15 modules to target the biopsychosocial components involved (2). In Study 1, individual in-depth interviews will be used to collect qualitative data on patients’ experiences, in order to refine the treatment. In Study 2, sequential single case AB design (SCED) with randomized baseline lengths will be used, and replicated in three health care contexts (3xN=10). Pain during touch or insertion of an object (e.g. tampon) is the primary outcome. Pain and psychosexual health will be measured weekly, and at pre, post and follow-up assessment. In Study 3, focus group and individual in-depth interviews will provide qualitative data on experiences from patients and professionals.
Results
Study 1 will inform adaptations of the treatment model, based on findings revealed through thematic analyses. Study 2 will present preliminary effectiveness results regarding pain and psychosexual health, based on visual inspection and complementary statistical analyses recommended for SCED studies. In Study 3, thematic analyses will be used to discover key aspects to consider when implementing the treatment model in clinical settings.
Conclusions
This study protocol describes a comprehensive clinical trial, aiming at developing and testing the feasibility, acceptability, and preliminary effects of a multimodal treatment for women with vulvodynia in a stepwise fashion. The results will contribute to a better understanding of how to treat this pain condition in a clinical context.
References
1.Bohm-Starke, N. (2010). Medical and physical predictors of localized provoked vulvodynia. Acta obstetricia et gynecologica Scandinavica, 89(12), 1504-1510.
2.Bohm-Starke, N., Ramsay, K. W., Lytsy, P., Nordgren, B., Sjöberg, I., Moberg, K., & Flink, I. (2022). Treatment of provoked vulvodynia: a systematic review. The journal of sexual medicine, 19(5), 789-808.
Presenting Author
Ida Flink
Poster Authors
Ida Flink
PhD
Karlstad University
Lead Author
Linnéa Engman
Ph.D.
Karolinska Institute
Lead Author
Emma Westerberg
Lic. Psychologist
Karlstad University
Lead Author
Rikard Wicksell
PhD
Karolinska Institute
Lead Author
Katja Boersma
PhD
School of Behavioral, Social and Legal Sciences, Örebro University
Lead Author
Nina Bohm-Starke
PhD
Karolinska Institute
Lead Author
Topics
- Specific Pain conditions/Pain in Specific Populations: Gynecological Pain