NCT04208204

Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study

Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Oslo Metropolitan University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This study examines feasibility of R\&D activities in the planned randomized controlled trial where effectiveness of somatocognitive therapy intervention will be compared to treatment as usual in provoked vestibulodynia.

Detailed description

Provoked vestibulodynia is a multifactorial, persistent pain condition, affecting young women. It represents the most common cause of pain during sexual intercourse. Existing treatment approaches are predominantly based on clinical experience, observational studies, or reports of expert committees. Although, physiotherapy is one of the most commonly recommended treatments, high quality randomized controlled trials are needed to assess its effectiveness. This is a phase I, feasibility study with the purpose of testing R\&D activities for a planned full size RCT. Additionally, patients experiences with the somatocognitive therapy intervention, assessment measures and condition itself will be collected using qualitative interviews. The results will be applied to adjust time-line of the treatment, outcome measures and therapeutic approach before commencing full scale RCT.

Conditions

• Provoked Vestibulodynia

Interventions

Type	Name	Description
OTHER	somatocognitive physiotherapy	Somatocognitive physiotherapy (SCT) is a multimodal physical therapy approach that has been developed in an attempt at alleviating the burden of longstanding pain. The main foci of SCT include: (1) bodily exercises and techniques increasing body awareness, ability to relax and control muscle tension in different situations; (2) education about the vulvodynia and factors influencing pain experience; (3) coping with emotions and thoughts related to bodily experiences; and (4) structured homework assignments promoting application of the learned techniques in daily situation and gradual exposure to activities associated with pain. An important goal of SCT is to facilitate integration of new bodily habits into the patient's daily activities. The most important learning process thus occurs in the space between the treatment sessions. The therapeutic techniques are to be rehearsed in everyday situations.

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2019-12-23
• Last updated: 2020-09-30

Locations

1 site across 1 country: Norway