Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis
Study Details
Study Description
Brief Summary
This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with endometriosis. 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 endometriosis 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 3 month PelvicSense(R) program 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. |
Behavioral: PelvicSense (R)
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.
|
Outcome Measures
Primary Outcome Measures
- Pain intensity [Baseline]
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).
- Pain intensity [At the end of the 3 month program]
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).
- Pain intensity [3 months after the end of the program]
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).
Secondary Outcome Measures
- Pain catastrophizing [Baseline]
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.
- Pain catastrophizing [At the end of the 3 month program]
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.
- Pain catastrophizing [3 months after the end of the program]
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.
Other Outcome Measures
- Sexual distress [Baseline]
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.
- Sexual distress [At the end of the 3 month 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.
- Sexual distress [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.
- Pain self-efficacy [Baseline]
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.
- Pain self-efficacy [At the end of the 3 month program]
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.
- Pain self-efficacy [3 months after the end of the program]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 18 years or older, fluent in English, and have a formal diagnosis of endometriosis for at least 3 months.
Exclusion Criteria:
- Younger than 18 years of age, nonfluency in English, self-identified diagnosis, endometriosis duration of less than 3 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sexual Health Research Laboratory, Department of Psychology, Queen's University | Kingston | Ontario | Canada | K7L 3N6 |
Sponsors and Collaborators
- Queen's University
Investigators
- Principal Investigator: Caroline Pukall, PhD, Queen's University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 379631-2