Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study

NCT04208204 | Completed

• 1 other identifier: 2018/1036
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Provoked Vestibulodynia

Keywords

provoked localized vulvodynia; provoked vestibulodynia; vestibulitt; physiotherapy

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Number of eligible patients and number of recruited participants per week

  5 months

• Follow-up rate

  The follow-up rate is measured by the percentage of participants who were followed up successfully until the 8 months follow-up

  8 months

• Adherence

  Adherence is defined as the number of participants who fully complete the battery of self-report questionnaires, 14-day diary, biweekly forms about the received treatment and perform Tampon tests.

  8 months

• Evaluation of Tampon test as a primary outcome measure - score variance

  Participants perform Tampon test 3 times in course of 14 days (day1, 7 and 14) at each of the 3 time points (baseline, post-treatment, 8 months after baseline), 9 scores in total. Numerical rating scale (0-10) will be used to score pain intensity. Intra-individual score variance will be estimated as difference between the min and max score at each time point for every participant. Lower variability is better.

  8 months

• Adverse events

  If participant is pulled out of the study because somatocognitive therapy is deemed as a non-appropriate treatment (e.g. participant is instead referred to psychological counselling), such event is recorded as adverse.

  8 months

• Evaluation of Tampon test as a primary outcome measure - qualitative interviews

  All participants are asked in individual qualitative interviews if they experience a Tampon test as a relevant instrument for assessing pain sensitivity experienced during intercourse.

  8 months

Secondary Outcomes (5)

• Implementation and acceptability of the somatocogntive therapy intervention

  8 months

• Evaluation of somatocognitive therapy intervention's potential to reduce pain

  8 months

• Evaluation of somatocognitive therapy intervention's potential to improve sexual functioning

  8 months

• Evaluation of somatocognitive therapy intervention's potential to reduce psychological distress

  8 months

• Evaluation of somatocognitive therapy intervention's potential to reduce pain catastrophizing

  8 months

Study Arms (1)

Somatocognitive physiotherapy

EXPERIMENTAL

Every participant will maximally receive 15 individual sessions of somatocognitive physiotherapy

Other: somatocognitive physiotherapy

Interventions

somatocognitive physiotherapy 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.

Somatocognitive physiotherapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed provoked vestibulodynia diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Oslo Metropolitan University

Oslo, 0130, Norway

Location

Related Publications (2)

• 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.

  PMID: 35321744 DERIVED

• 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.

  PMID: 33967000 DERIVED

Study Officials

• Slawomir Wojniusz, PhD

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: December 23, 2019
• Study Start: February 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)