Public defence: Mette Bøymo Kaarbø

Provoked vestibulodynia (PVD) is a prevalent chronic pain condition adversely affecting women’s sexual life, the relation to their partners and their psychological health. Pain is localised to the vulvar vestibule and is provoked by physical contact, such as penetrative intercourse.

There is an urgent need for well-designed randomised clinical trials (RCTs) to identify the most effective interventions for this neglected women’s health condition. Somatocognitive therapy (SCT) is a multimodal physiotherapy treatment which has in recent years been further developed for PVD.

Aims

The main aims of this PhD thesis were

• to assess the feasibility and acceptability of SCT for women with PVD in preparation for a full-scale RCT
• to evaluate the tampon test as a primary outcome measure in preparation for the main trial
• to explore women’s experiences with SCT and gain further insight into meaningful processes towards improved sexual health
• to develop a conceptual model for PVD with SCT including a detailed description of SCT as a treatment for PVD.

Methods

This thesis is based on data from a feasibility study and uses quantitative and qualitative methods. Paper I-III is based on data from ten women with PVD, aged 18-33, recruited from the Vulva Clinic, Oslo University Hospital.

Paper I is a multimethod study with a single arm before-after trial and qualitative interviews, the latter undertaken at two time points. The women were treated with SCT at Oslo Metropolitan University. Tampon tests and self-report questionnaires were undertaken at baseline, post-treatment and at 8 months follow-up.

The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools and follow-up rate. Experiences with the outcome measures and the SCT intervention were explored with semi-structured interviews.

Paper II is a mixed methods study utilising an explanatory sequential design, integrating quantitative and qualitative methods to evaluate the tampon test as a primary outcome measure.

In phase one, pain intensity levels were evaluated with the tampon test on day 1, 7 and 14, and rated on the Numerical Rating Scale (NRS), (0-10), 10 being worst possible pain. In phase two, the participants’ experiences with the test were explored with semi-structured interviews.

Paper III is a qualitative study, where the women were interviewed towards the end of the treatment period and one year later to develop insight into therapeutic processes unfolding over time. Following the thematic analysis by Braun and Clarke (2006), the data were analysed inductively. In

Paper IV a conceptual model for PVD with SCT was developed based on findings in the feasibility study (Paper I and III), past research and clinical experience.

Conclusions

The integration of quantitative and qualitative work in this thesis suggests that it is feasible to deliver a full-scale RCT to evaluate the effect of SCT versus standard PVD treatment for women with PVD. Some changes are suggested, such as increasing recruitment sites, change of primary outcome measure and adding a booster session.

The findings of Paper II indicate several problems with the application of the tampon test as a primary outcome measure in PVD. The tampon test may be more useful as a secondary outcome, preferably undertaken repeatedly in order to increase precision of the pain estimation.

The findings indicate that SCT is a promising intervention for women with PVD. The findings further suggest that SCT can support meaningful processes towards improved sexual health.

Findings from Paper I and III lead to a refinement of the SCT intervention and to the development of a conceptual model for PVD with SCT. Providing an in-depth and complete description of SCT allows replication in clinical practice and clinical trials.