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

Not Applicable

Completed

• Conditions: Chronic Female Pelvic Pain Syndrome (Disorder)
• Interventions: Behavioral: Mindfulness counseling

• Registration Number: NCT04773925
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-26
• Study Start: 2021-03-23
• Status Verified: 2021-11
• Primary Completion: 2021-11-02
• Study Completion: 2021-11-02
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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.

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Exclusion Criteria

• Diagnoses of primarily non-gynecologic pain, acute pelvic pain, and active abdominal or pelvic malignancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness group	Mindfulness counseling	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.

Primary Outcome Measures

Name	Time	Method
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	6 months	This outcome measure will demonstrate whether the proposed intervention showed improvement in symptomatology of subjects with chronic pain.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States