Clinical trial NCT04208204: Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study
Official title: Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Provoked Vestibulodynia
Keywords: provoked localized vulvodynia
provoked vestibulodynia
vestibulitt
physiotherapy
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2019-12-23
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Three measurements time points: baseline, after treatment, and 8 months after baseline. Additionally two interviews per participant; first - between baseline and treatment ending and second after 8 months follow up
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed provoked vestibulodynia diagnosis

Exclusion Criteria:

* vulvar pain is not clearly linked to intercourse or pressure applied to vestibule or usage of tampon
* active infection or dermatologic lesion in the vulvar region

Primary outcomes:
measure: Recruitment rate
timeFrame: 5 months
measure: Follow-up rate
timeFrame: 8 months
measure: Adherence
timeFrame: 8 months
measure: Evaluation of Tampon test as a primary outcome measure - score variance
timeFrame: 8 months
measure: Adverse events
timeFrame: 8 months
measure: Evaluation of Tampon test as a primary outcome measure - qualitative interviews
timeFrame: 8 months
Secondary outcomes:
measure: Implementation and acceptability of the somatocogntive therapy intervention
timeFrame: 8 months
measure: Evaluation of somatocognitive therapy intervention's potential to reduce pain
timeFrame: 8 months
measure: Evaluation of somatocognitive therapy intervention's potential to improve sexual functioning
timeFrame: 8 months
measure: Evaluation of somatocognitive therapy intervention's potential to reduce psychological distress
timeFrame: 8 months
measure: Evaluation of somatocognitive therapy intervention's potential to reduce pain catastrophizing
timeFrame: 8 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Metropolitan University
Study officials:
affiliation: Oslo Metropolitan University
name: Slawomir Wojniusz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaarbo MB, Danielsen KG, Haugstad GK, Helgesen ALO, Wojniusz S. Feasibility and acceptability of somatocognitive therapy in the management of women with provoked localized vestibulodynia-ProLoVe feasibility study. Pilot Feasibility Stud. 2022 Mar 23;8(1):68. doi: 10.1186/s40814-022-01022-2.
citation: Kaarbo MB, Danielsen KG, Haugstad GK, Helgesen ALO, Wojniusz S. The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study. J Sex Med. 2021 Jun;18(6):1083-1091. doi: 10.1016/j.jsxm.2021.03.010. Epub 2021 May 6.