## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 379631-2
#### Organization
**Class:** OTHER
**Full Name:** Queen's University
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2023-06-18
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-05
**Study First Submit QC Date:** 2023-06-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dr. Caroline Pukall

#### Responsible Party

**Investigator Affiliation:** Queen's University

**Investigator Full Name:** Dr. Caroline Pukall

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Endometriosis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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 Names:**

- Behavioral: PelvicSense (R)

**Label:** 3 month PelvicSense(R) program

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 3 month PelvicSense(R) program

**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.

**Name:** PelvicSense (R)

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**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.

**Measure:** Sexual distress

**Time Frame:** Baseline

**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.

**Measure:** Sexual distress

**Time Frame:** At the end of the 3 month program

**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.

**Measure:** Sexual distress

**Time Frame:** 3 months after the end of the program

**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.

**Measure:** Pain self-efficacy

**Time Frame:** Baseline

**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.

**Measure:** Pain self-efficacy

**Time Frame:** At the end of the 3 month program

**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.

**Measure:** Pain self-efficacy

**Time Frame:** 3 months after the end of the program

#### Primary Outcomes

**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).

**Measure:** Pain intensity

**Time Frame:** Baseline

**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).

**Measure:** Pain intensity

**Time Frame:** At the end of the 3 month program

**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).

**Measure:** Pain intensity

**Time Frame:** 3 months after the end of the program

#### Secondary Outcomes

**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.

**Measure:** Pain catastrophizing

**Time Frame:** Baseline

**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.

**Measure:** Pain catastrophizing

**Time Frame:** At the end of the 3 month program

**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.

**Measure:** Pain catastrophizing

**Time Frame:** 3 months after the end of the program

### Eligibility Module

**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.

**Gender Based:** True

**Gender Description:** All identities accepted with female pelvic anatomy.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** caroline.pukall@queensu.ca

**Name:** Caroline Pukall, PhD

**Phone:** 613 533 3200

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Kingston

**Contacts:**

***Contact 1:***

- **Email:** caroline.pukall@queensu.ca

- **Name:** Caroline Pukall, PhD

- **Phone:** 613 533 3200

- **Role:** CONTACT

***Contact 2:***

- **Email:** shannon.coyle13@gmail.com

- **Name:** Shannon Coyle, MA

- **Phone:** 613 533 3276

- **Role:** CONTACT

**Country:** Canada

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

**State:** Ontario

**Status:** RECRUITING

**Zip:** K7L 3N6

#### Overall Officials

**Official 1:**

**Affiliation:** Queen's University

**Name:** Caroline Pukall, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Please email the PI at caroline.pukall@queensu.ca

**Description:** De-identified data will be available to other researchers after publication of the results.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** De-identified data will be available to other researchers for 2 years after publication of the results.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7877

- Name: Endometriosis

- Relevance: HIGH

- As Found: Endometriosis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004715

- Term: Endometriosis

### Misc Info Module

- Version Holder: 2024-05-24
