Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2022-05-16
2023-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The somatosensory rehabilitation program includes minimizing contact with the painful zone of the vulva and uses repeated tactile stimulation at a tolerated distance, proximal to the vulva. The pain management program includes teaching participants about vulvar hygiene, chronic pain mechanisms, relaxation techniques, and approaches to reduce skin irritations in painful regions. Participants in both groups will also receive advice on sexual function and steps toward resuming sexual activities with vaginal penetration.
Feasibility and acceptability outcomes will be assessed and analyzed using descriptive statistics for the adherence rates to treatment sessions and home exercises, the recruitment rate, retention rate, satisfaction, and adverse effects. The results will be compared to predetermined thresholds to determine the feasibility and acceptability of a future clinical trial.
Secondary measures will be assessed at baseline, two weeks after the treatment, and at three months follow-up. These outcomes will be assessed using validated questionnaires (pain, sexual function, global impression of change, psychological variables, quality of life) as well as evaluations of tactile and pressure sensitivity in vulvar regions using monofilaments, a 2-point aesthesiometer and an algometer. Linear mixed models for repeated measurements (2 groups, 3 measurement times) will be used to explore the treatment effects and will contribute to determining the feasibility of a future clinical trial.
Hypothesis and expected results: It is expected that both programs will meet the pre-determined criteria for acceptability and feasibility in women with provoked vestibulodynia. This study will provide guidance for a future randomized clinical trial.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study
NCT04208204
Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia
NCT01455350
Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain
NCT03493308
Integrated Mindfulness for Provoked Vestibulodynia
NCT01704443
Using Peripheral Neurostimulation to Improve Work Rehabilitation
NCT05316623
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Somatosensory Rehabilitation Program
Includes minimizing contact with the painful zone of the vulva and uses tactile stimulation at a tolerated distance from the vulva. Each participant will also receive advice on resuming sexual activities with vaginal penetration.
Somatosensory Rehabilitation Program
Somatosensory rehabilitation program includes minimizing contact with the painful zone of the vulva and uses tactile stimulation at a tolerated distance from the vulva. Each participant will also receive advice on resuming sexual activities with vaginal penetration.
Educational Pain Management Program (PMP)
Includes education on decreasing irritative contacts with the vulva and relaxation techniques. Each participant will also receive advice on resuming sexual activities with vaginal penetration.
Educational Pain Management Program
Educational Pain Management Program includes education on decreasing irritative contacts with the vulva and relaxation techniques. Each participant will also receive advice on resuming sexual activities with vaginal penetration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Somatosensory Rehabilitation Program
Somatosensory rehabilitation program includes minimizing contact with the painful zone of the vulva and uses tactile stimulation at a tolerated distance from the vulva. Each participant will also receive advice on resuming sexual activities with vaginal penetration.
Educational Pain Management Program
Educational Pain Management Program includes education on decreasing irritative contacts with the vulva and relaxation techniques. Each participant will also receive advice on resuming sexual activities with vaginal penetration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Moderate to severe pain (≥5/10) located in the vulvar vestibule for at least 90% of vaginal penetrations or attempted vaginal penetrations or activities with pressure on the vagina for at least 3 months
Exclusion Criteria
2. Prior vulvo-vaginal surgery or radiotherapy
3. Post-menopausal status
4. Participant refusal to not use other treatments for the provoked vestibulodynia during the entire study (until 3 months post-treatment);
5. Other urogynecological condition (e.g. pelvic organs prolapse ≥3, current urinary/vaginal infection or in the last 3 months)
6. Prior use of Somatosensory Rehabilitation Program or Educational Pain Management Program
7. Current or past pregnancy in the last year;
8. Changes of medication that could influence pain perception (e.g. analgesic, antidepressant) in the last 3 months
9. Major psychological condition (e.g. depressive symptoms, anxiety) which can present a security issue for the participant
10. Other medical conditions that could interfere with the study
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
OTHER
Université de Sherbrooke
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mélanie Morin
Researcher and Full Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Facebook page
Laboratory Web page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
#2022-4357
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.