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Clinical Trials/NCT04773925
NCT04773925
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country15 target enrollmentMarch 23, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Female Pelvic Pain Syndrome (Disorder)
Sponsor
Mayo Clinic
Enrollment
15
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 23, 2021
End Date
November 2, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aakriti R. Carrubba

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of chronic pelvic pain.
  • Must speak English.
  • Must be ages 18 through
  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 6 months

This outcome measure will demonstrate whether the proposed intervention showed improvement in symptomatology of subjects with chronic pain.

Secondary Outcomes

  • Number of participants who were able to attend all mind-body training sessions(6 months)
  • Time from enrollment in the study until completion of all mind-body sessions(6 months)

Study Sites (1)

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