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

Primary Purpose

Chronic Female Pelvic Pain Syndrome (Disorder)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness counseling
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Female Pelvic Pain Syndrome (Disorder)

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness group

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 23, 2021
Last Updated
November 4, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04773925
Brief Title
The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain
Official Title
The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Female Pelvic Pain Syndrome (Disorder)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
This outcome measure will demonstrate whether the proposed intervention showed improvement in symptomatology of subjects with chronic pain.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants who were able to attend all mind-body training sessions
Description
This outcome measure will be used to determine adherence and attendance to the Integrative Medicine services.
Time Frame
6 months
Title
Time from enrollment in the study until completion of all mind-body sessions
Description
This outcome measure will determine feasibility of scheduling patients with Integrative Medicine services and determine waiting list times for this service.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aakriti R Carrubba, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28089309
Citation
Alders I, Smits C, Brand P, van Dulmen S. Does patient coaching make a difference in patient-physician communication during specialist consultations? A systematic review. Patient Educ Couns. 2017 May;100(5):882-896. doi: 10.1016/j.pec.2016.12.029. Epub 2016 Dec 29.
Results Reference
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PubMed Identifier
31725209
Citation
Lachance CC, McCormack S. Mindfulness Training and Yoga for the Management of Chronic Non-malignant Pain: A Review of Clinical Effectiveness and Cost-effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Sep 20. Available from http://www.ncbi.nlm.nih.gov/books/NBK549581/
Results Reference
background
PubMed Identifier
27612341
Citation
Crisp CD, Hastings-Tolsma M, Jonscher KR. Mindfulness-Based Stress Reduction for Military Women With Chronic Pelvic Pain: A Feasibility Study. Mil Med. 2016 Sep;181(9):982-9. doi: 10.7205/MILMED-D-15-00354.
Results Reference
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PubMed Identifier
28961631
Citation
Ball EF, Nur Shafina Muhammad Sharizan E, Franklin G, Rogozinska E. Does mindfulness meditation improve chronic pain? A systematic review. Curr Opin Obstet Gynecol. 2017 Dec;29(6):359-366. doi: 10.1097/GCO.0000000000000417.
Results Reference
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PubMed Identifier
31570137
Citation
Jaderek I, Lew-Starowicz M. A Systematic Review on Mindfulness Meditation-Based Interventions for Sexual Dysfunctions. J Sex Med. 2019 Oct;16(10):1581-1596. doi: 10.1016/j.jsxm.2019.07.019.
Results Reference
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PubMed Identifier
18507718
Citation
Brotto LA, Basson R, Luria M. A mindfulness-based group psychoeducational intervention targeting sexual arousal disorder in women. J Sex Med. 2008 Jul;5(7):1646-59. doi: 10.1111/j.1743-6109.2008.00850.x.
Results Reference
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PubMed Identifier
29335232
Citation
Ball E, Newton S, Kahan BC, Forbes G, Wright N, Cantalapiedra Calvete C, Gibson HAL, Rogozinska E, Rivas C, Taylor SJC, Birch J, Dodds J. Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial. JMIR Res Protoc. 2018 Jan 15;7(1):e8. doi: 10.2196/resprot.7720.
Results Reference
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PubMed Identifier
32165549
Citation
Forbes G, Newton S, Cantalapiedra Calvete C, Birch J, Dodds J, Steed L, Rivas C, Khan K, Rohricht F, Taylor S, Kahan BC, Ball E. MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial. BMJ Open. 2020 Mar 12;10(3):e030164. doi: 10.1136/bmjopen-2019-030164.
Results Reference
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PubMed Identifier
31103481
Citation
Brotto LA, Bergeron S, Zdaniuk B, Driscoll M, Grabovac A, Sadownik LA, Smith KB, Basson R. A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting. J Sex Med. 2019 Jun;16(6):909-923. doi: 10.1016/j.jsxm.2019.04.002. Epub 2019 May 15.
Results Reference
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Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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