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

Chronic Female Pelvic Pain Syndrome (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773925
• Other study ID #: 21-000221
• Status: Completed
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: November 2, 2021

Study information

• Verified date: November 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Female Pelvic Pain Syndrome (Disorder)
• Pelvic Pain

Intervention

Behavioral:
• Mindfulness counseling
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Forbes G, Newton S, Cantalapiedra Calvete C, Birch J, Dodds J, Steed L, Rivas C, Khan K, Röhricht 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. — View 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. — View Citation

Lachance, C.C. and S. McCormack, in Mindfulness Training and Yoga for the Management of Chronic Non-malignant Pain: A Review of Clinical Effectiveness and Cost-effectiveness. 2019: Ottawa (ON).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months

External Links

•   Mayo Clinic Clinical Trials