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

Primary Purpose

Provoked Vestibulodynia

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

PelvicSense(R)

About this trial

This is an interventional treatment trial for Provoked Vestibulodynia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 18 years or older fluent in English have a formal diagnosis of PVD for at least 3 months Exclusion Criteria: younger than 18 years of age nonfluent in English self-identified diagnosis PVD duration of less than 3 months

Sites / Locations

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

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

NCT ID

NCT05909514

First Posted

May 5, 2023

Last Updated

June 23, 2023

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT05909514

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 25, 2023 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

March 31, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Provoked Vestibulodynia

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

Intervention Type

Behavioral

Intervention Name(s)

PelvicSense(R)

Intervention Description

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. Higher scores are better.

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

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Pukall, PhD

Phone

613 533 3200

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caroline Pukall, PhD

Phone

613 533 3200

caroline.pukall@queensu.ca

First Name & Middle Initial & Last Name & Degree

Shannon Coyle, MA

Phone

613 533 3276

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 Provoked Vestibulodynia

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