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Completed

NCT Number: NCT04208204

Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study

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.

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Key information

Conditions

Provoked Vestibulodynia

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oslo Metropolitan University

Oslo, 0130, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Acronym: ProLoVe

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2019
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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