Skip to main content
OpenTrials
Completed

NCT Number: NCT05909579

Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sexual Health Research Laboratory, Department of Psychology, Queen's University

Kingston, Ontario, K7L 3N6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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).

  2. Pain intensity

    Time frame: 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).

  3. Pain intensity

    Time frame: 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 outcomes

  1. Pain catastrophizing

    Time frame: 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.

  2. Pain catastrophizing

    Time frame: 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.

  3. Pain catastrophizing

    Time frame: 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 outcomes

  1. Sexual distress

    Time frame: 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.

  2. Sexual distress

    Time frame: 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.

  3. Sexual distress

    Time frame: 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.

  4. Pain self-efficacy

    Time frame: 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.

  5. Pain self-efficacy

    Time frame: 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.

  6. Pain self-efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. Caroline Pukall

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.