Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study

NCT ID: NCT04208204

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-07-31

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.

Conditions

Provoked Vestibulodynia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Somatocognitive physiotherapy

Every participant will maximally receive 15 individual sessions of somatocognitive physiotherapy

Group Type: EXPERIMENTAL

somatocognitive physiotherapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Oslo Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Slawomir Wojniusz, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo Metropolitan University

Locations

Oslo Metropolitan University

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 35321744 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33967000 (View on PubMed)

Other Identifiers

2018/1036

Identifier Type: -

Identifier Source: org_study_id