The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain
Condition: Chronic Female Pelvic Pain Syndrome (Disorder)
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Mindfulness counseling
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Supportive Care