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Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study (ProLoVe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208204
Recruitment Status : Active, not recruiting
First Posted : December 23, 2019
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Oslo Metropolitan University

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.

Condition or disease Intervention/treatment Phase
Provoked Vestibulodynia Other: somatocognitive physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Somatocognitive physiotherapy
Every participant will maximally receive 15 individual sessions of somatocognitive physiotherapy
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.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 5 months ]
    Number of eligible patients and number of recruited participants per week

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Implementation and acceptability of the somatocogntive therapy intervention [ Time Frame: 8 months ]
    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.

  2. Evaluation of somatocognitive therapy intervention's potential to reduce pain [ Time Frame: 8 months ]
    Changes in individual mean scores (0-10, the lower score the better) of pain experienced during tampon test between 3 measurements time points.

  3. Evaluation of somatocognitive therapy intervention's potential to improve sexual functioning [ Time Frame: 8 months ]
    Changes in individual scores on Female Sexual Function Index between 3 measurements time points. Scale ranges 0-36, higher score means better sexual functioning.

  4. Evaluation of somatocognitive therapy intervention's potential to reduce psychological distress [ Time Frame: 8 months ]
    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.

  5. Evaluation of somatocognitive therapy intervention's potential to reduce pain catastrophizing [ Time Frame: 8 months ]
    Changes in individual scores on Pain Catastrophizing Scale between 3 different time points. Scale ranges 0-52, the lower score represents less pain catastrophizing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208204


Locations
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Norway
Oslo Metropolitan University
Oslo, Norway, 0130
Sponsors and Collaborators
Oslo Metropolitan University
Oslo University Hospital
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Responsible Party: Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT04208204    
Other Study ID Numbers: 2018/1036
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oslo Metropolitan University:
provoked localized vulvodynia
provoked vestibulodynia
vestibulitt
physiotherapy
Additional relevant MeSH terms:
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Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis