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This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with provoked vestibulodynia. This study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. All aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in English, and experience pain due to provoked vestibulodynia for at least 3 months with a physician diagnosis. Participants are expected to continue their treatment as usual and this information will be documented throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 month PelvicSense(R) program | Experimental | PelvicSense® is a home-based physiotherapy program integrating multiple techniques, including relaxation, breathing, stretching, strengthening and at-home manual therapy. This program also educates participants about the anatomy and physiology of the pelvis and teaches strategies to strengthen the mind-muscle connection to the pelvis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PelvicSense(R) | Behavioral | PelvicSense® is a home-based physiotherapy program integrating multiple techniques, including relaxation, breathing, stretching, strengthening and at-home manual therapy. This program also educates participants about the anatomy and physiology of the pelvis and teaches strategies to strengthen the mind-muscle connection to the pelvis. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt). | Baseline |
| Pain intensity | Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt). | At the end of the 3 month program |
| Pain intensity | Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt). | 3 months after the end of the program |
| Measure | Description | Time Frame |
|---|---|---|
| Pain catastrophizing | Pain Catastrophizing Scale (PCS). 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse. | Baseline |
| Pain catastrophizing |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual distress | Sexual Distress Scale, Short Form (SDS-SF). 5 items rated on 5 point scales from 0 (never) to 4 (always). Total scores range from 0-20. Higher scores are worse. | Baseline |
| Sexual distress |
Inclusion Criteria:
Exclusion Criteria:
All identities accepted with female pelvic anatomy.
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Pukall, PhD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sexual Health Research Laboratory, Department of Psychology, Queen's University | Kingston | Ontario | K7L 3N6 | Canada |
De-identified data will be available to other researchers after publication of the results.
De-identified data will be available to other researchers for 2 years after publication of the results.
Please email the PI at caroline.pukall@queensu.ca
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Pain Catastrophizing Scale (PCS). 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.
| At the end of the 3 month program |
| Pain catastrophizing | Pain Catastrophizing Scale (PCS). 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse. | 3 months after the end of the program |
Sexual Distress Scale, Short Form (SDS-SF). 5 items rated on 5 point scales from 0 (never) to 4 (always). Total scores range from 0-20. Higher scores are worse.
| At the end of the 3 month program |
| Sexual distress | Sexual Distress Scale, Short Form (SDS-SF). 5 items rated on 5 point scales from 0 (never) to 4 (always). Total scores range from 0-20. Higher scores are worse. | 3 months after the end of the program |
| Pain self-efficacy | Pain Self-Efficacy Questionnaire (PSEQ). 10 items rated on 7 point scales from 0 (not at all confident) to 6 (completely confident). Total scores range from 0-60. Higher scores are better. | Baseline |
| Pain self-efficacy | Pain Self-Efficacy Questionnaire (PSEQ). 10 items rated on 7 point scales from 0 (not at all confident) to 6 (completely confident). Total scores range from 0-60. | At the end of the 3 month program |
| Pain self-efficacy | Pain Self-Efficacy Questionnaire (PSEQ). 10 items rated on 7 point scales from 0 (not at all confident) to 6 (completely confident). Total scores range from 0-60. | 3 months after the end of the program |