The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain

Study Overview
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Brief Summary
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The purpose of this research is to determine if mind and body counseling and training improves quality of life in women undergoing treatment for chronic pelvic pain.

Detailed Description
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Patients with chronic illnesses are expected to self-manage much of their treatment. Barriers include limited time during appointments, consultations with multiple different providers, technical communication style, health literacy issues, and a sense of feeling overwhelmed. Patients with chronic pain syndromes experience symptoms which can negatively impact their quality of life by interfering with ability to sleep, work, and function in their social roles. One proposed mechanism in chronic pain management is mindfulness. Mindfulness is the intentional and non-judgmental conscious awareness of the present moment, or paying attention on purpose with the goal of physical and psychological health improvement. Participants are taught autonomy, increasing self-regulation, and focusing awareness on a particular goal or activity. The investigators hypothesize that a mind-body counselor will improve patient engagement and promote adherence to pain coping treatments. If the initial findings from this project support the use of Integrative Medicine services in women with chronic pelvic pain, the investigators hope to expand this study to a larger, randomized controlled trial that is adequately powered to determine significant difference among participants in the control and study groups.

Official Title
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The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain

Conditions
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Chronic Female Pelvic Pain Syndrome (Disorder)

Intervention / Treatment
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* Behavioral: Mindfulness counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronic pelvic pain. Must speak English. Must be ages 18 through 89. Must be willing and able to provide informed consent for participation. Must have access to the Patient Online Services portal to complete the questionnaires. Exclusion Criteria: - Diagnoses of primarily non-gynecologic pain, acute pelvic pain, and active abdominal or pelvic malignancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Women with chronic pelvic pain will be recruited during outpatient visits to Mayo Clinic Florida. Baseline patient-reported outcomes will be obtained using the PROMIS-CAT questionnaire. Questionnaires will be assigned in the electronic medical record. All subjects will receive standard care for their chronic pelvic pain, including a consultation with a gynecologist. Patients will then be referred for three 60-minute mindfulness counseling sessions conducted via telemedicine with a certified Mind-Body Counselor who has a degree in Social Work in the department of Integrative Medicine. The initial consultation will consist of a 60-minute individual session. The subsequent sessions will be group visits (anticipate 5 subjects per group) lasting 60 minutes. PROMIS-CAT questionnaires will be repeated at 3 months and 6 months, and a satisfaction survey will be distributed at the completion of the program.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness group<br>As this is a pilot feasibility trial, there is only one arm. All subjects will receive the mindfulness intervention if they consent to participate in the study. | Behavioral: Mindfulness counseling<br>* Subjects three 60-minute mindfulness counseling sessions with a certified Mind-Body Counselor who has a degree in Social Work in the department of Integrative Medicine. The mindfulness sessions will be conducted entirely via telemedicine. The initial consultation will consist of a 60-minute individual session. The next session will be a group visit (plan for 5 subjects per group) lasting 60 minutes, which will be scheduled for 2 weeks after the initial session. The third session will be another 60-minute group session, which will be scheduled for 6 weeks after the initial session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with improved quality of life scores on PROMIS-CAT questionnaires after treatment of chronic pelvic pain and enrollment in a mind-body training program | This outcome measure will demonstrate whether the proposed intervention showed improvement in symptomatology of subjects with chronic pain. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who were able to attend all mind-body training sessions | This outcome measure will be used to determine adherence and attendance to the Integrative Medicine services. | 6 months | 
| Time from enrollment in the study until completion of all mind-body sessions | This outcome measure will determine feasibility of scheduling patients with Integrative Medicine services and determine waiting list times for this service. | 6 months |