Back to resultsInvestigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis
Primary Purpose
Endometriosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PelvicSense (R)
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility 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.
Sites / Locations
- Sexual Health Research Laboratory, Department of Psychology, Queen's University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3 month PelvicSense(R) program
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
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).
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).
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05909579
Brief Title
Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis
Official Title
Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 month PelvicSense(R) program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PelvicSense (R)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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).
Time Frame
Baseline
Title
Pain intensity
Description
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).
Time Frame
At the end of the 3 month program
Title
Pain intensity
Description
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).
Time Frame
3 months after the end of the program
Secondary Outcome Measure Information:
Title
Pain catastrophizing
Description
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.
Time Frame
Baseline
Title
Pain catastrophizing
Description
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.
Time Frame
At the end of the 3 month program
Title
Pain catastrophizing
Description
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.
Time Frame
3 months after the end of the program
Other Pre-specified Outcome Measures:
Title
Sexual distress
Description
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.
Time Frame
Baseline
Title
Sexual distress
Description
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.
Time Frame
At the end of the 3 month program
Title
Sexual distress
Description
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.
Time Frame
3 months after the end of the program
Title
Pain self-efficacy
Description
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.
Time Frame
Baseline
Title
Pain self-efficacy
Description
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.
Time Frame
At the end of the 3 month program
Title
Pain self-efficacy
Description
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.
Time Frame
3 months after the end of the program
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
All identities accepted with female pelvic anatomy.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Pukall, PhD
Phone
613 533 3200
Email
caroline.pukall@queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Pukall, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sexual Health Research Laboratory, Department of Psychology, Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Pukall, PhD
Phone
613 533 3200
Email
caroline.pukall@queensu.ca
First Name & Middle Initial & Last Name & Degree
Shannon Coyle, MA
Phone
613 533 3276
Email
shannon.coyle13@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be available to other researchers after publication of the results.
IPD Sharing Time Frame
De-identified data will be available to other researchers for 2 years after publication of the results.
IPD Sharing Access Criteria
Please email the PI at caroline.pukall@queensu.ca
Learn more about this trial
Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis
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