Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Recruitment rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: 5 months
Number of eligible patients and number of recruited participants per week
Evaluation of Tampon test as a primary outcome measure - qualitative interviews
Time Frame: 8 months
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.
Adherence
Time Frame: 8 months
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.
Follow-up rate
Time Frame: 8 months
The follow-up rate is measured by the percentage of participants who were followed up successfully until the 8 months follow-up
Evaluation of Tampon test as a primary outcome measure - score variance
Time Frame: 8 months
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.
Adverse events
Time Frame: 8 months
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.
Secondary Outcomes
- Implementation and acceptability of the somatocogntive therapy intervention(8 months)
- Evaluation of somatocognitive therapy intervention's potential to reduce pain catastrophizing(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)