Provoked VestibulodyniaProLoVeNCT04208204
Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study
A study testing somatocognitive physiotherapy in people with Provoked Vestibulodynia, run by Oslo Metropolitan University at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Provoked Vestibulodynia
- What is being tested?
- somatocognitive physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Confirmed provoked vestibulodynia diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience
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.
Read the 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.
- Conditions
- Provoked Vestibulodynia
- Being tested
- somatocognitive physiotherapy
- Keywords
- provoked localized vulvodynia, provoked vestibulodynia, vestibulitt, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatocognitive physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Somatocognitive physiotherapy | Experimental | Every participant will maximally receive 15 individual sessions of somatocognitive physiotherapy Receives: Other: somatocognitive physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of eligible patients and number of recruited participants per week
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (5)
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.
Measured: 8 months
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.
Measured: 8 months
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.
Measured: 8 months
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.
Measured: 8 months
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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Feb 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Provoked VestibulodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Slawomir Wojniusz, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208204
- Sponsor's protocol ID
- 2018/1036
- Acronym
- ProLoVe
- Status last verified
- Sep 2020
- First submitted
- 30 Oct 2019
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35321744Kaarbo 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.
PubMed 33967000
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience
- ClinicalTrials.gov ID
- NCT04208204
- Acronym / sponsor ID
- ProLoVe / 2018/1036
- Conditions
- Provoked Vestibulodynia
- Keywords
- provoked localized vulvodynia, provoked vestibulodynia, vestibulitt, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Somatocognitive physiotherapy | Experimental | Other: somatocognitive physiotherapyEvery participant will maximally receive 15 individual sessions of somatocognitive physiotherapy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Confirmed provoked vestibulodynia diagnosis
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatocognitive physiotherapySomatocognitive 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. | Other | Somatocognitive physiotherapy |
Primary outcome
Recruitment rate
Time frame: 5 months
Number of eligible patients and number of recruited participants per week
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
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.
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.
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.
5 secondary outcomes
Implementation and acceptability of the somatocogntive therapy intervention
Time frame: 8 months
Evaluation of somatocognitive therapy intervention's potential to reduce pain
Time frame: 8 months
Evaluation of somatocognitive therapy intervention's potential to improve sexual functioning
Time frame: 8 months
Evaluation of somatocognitive therapy intervention's potential to reduce psychological distress
Time frame: 8 months
Evaluation of somatocognitive therapy intervention's potential to reduce pain catastrophizing
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 35321744Kaarbo 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.
- Derived from this study: PubMed 33967000Kaarbo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Slawomir Wojniusz, PhD principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing somatocognitive physiotherapy in people with Provoked Vestibulodynia, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208204, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.