Clinical trial NCT04773925: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Female Pelvic Pain Syndrome (Disorder)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants who were able to attend all mind-body training sessions
timeFrame: 6 months
measure: Time from enrollment in the study until completion of all mind-body sessions
timeFrame: 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Aakriti R Carrubba, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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/
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.
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.
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.
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.
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.
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.
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.