Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study

Provoked Vestibulodynia Clinical Trial

— ProLoVe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208204
• Other study ID #: 2018/1036
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2020
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Provoked Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo Metropolitan University	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of eligible patients and number of recruited participants per week	5 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Implementation and acceptability of the somatocogntive therapy intervention	Participants will be asked in qualitative interviews about their experiences with somatocogntitve therapy intervention. Global Rating of Change scale will be used to provide quantitative estimation of participants' satisfaction with the treatment effect directly after treatment and at 8 months follow-up. The scale ranges from 1 to 6. Score of 1 means that treatment helped a lot and the score of 6 means that the treatment made the condition much worse.	8 months
Secondary	Evaluation of somatocognitive therapy intervention's potential to reduce pain	Changes in individual mean scores (0-10, the lower score the better) of pain experienced during tampon test between 3 measurements time points.	8 months
Secondary	Evaluation of somatocognitive therapy intervention's potential to improve sexual functioning	Changes in individual scores on Female Sexual Function Index between 3 measurements time points. Scale ranges 0-36, higher score means better sexual functioning.	8 months
Secondary	Evaluation of somatocognitive therapy intervention's potential to reduce psychological distress	Changes in individual scores on Hopkins Symptom Check List - 25 questions version between 3 measurements time points. Scale ranges 1-4, lower score indicates less psychological distress.	8 months
Secondary	Evaluation of somatocognitive therapy intervention's potential to reduce pain catastrophizing	Changes in individual scores on Pain Catastrophizing Scale between 3 different time points. Scale ranges 0-52, the lower score represents less pain catastrophizing	8 months