Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain

University of Michigan

Status: Completed

Conditions: Chronic Pelvic Pain; Endometriosis

Treatments: Behavioral: My Pelvic Plan Website; Behavioral: Control Group website

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06352840

5K23HD099283-03 (U.S. NIH Grant/Contract)

HUM00231526

Details and patient eligibility

About

The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).

The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.

Enrollment: 69 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
• Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain
• Access to internet via computer or smartphone
• English-language proficiency (current version of the website is in English)

Exclusion criteria

• Underwent gynecologic surgery within 3 months of screening visit
• Plan to undergo gynecologic surgery within 6 months following screening visit
• Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study.
• Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
• Current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder),
• Current suicidal ideation or suicide attempt within 2 years of screening visit. The study will screen for severe depression and suicidality at each questionnaire time point and have developed a robust triage and referral plan.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 2 patient groups

Monitoring progress plus usual care

Other group

Description:

Participants will have access to the monitoring progress web-based symptom monitoring program.

Treatment:

Behavioral: Control Group website

My Pelvic Plan plus usual care

Experimental group

Description:

Participants will have access to My Pelvic Plan program.

Treatment:

Behavioral: My Pelvic Plan Website