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

Mayo Clinic

Status: Completed

Conditions: Chronic Female Pelvic Pain Syndrome (Disorder)

Treatments: Behavioral: Mindfulness counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04773925

21-000221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Mindfulness group

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness counseling