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Iyengar Yoga Therapy for Dysmenorrhea and Endometriosis

Primary Purpose

Secondary Dysmenorrhea, Dysmenorrhea, Dysmenorrhea Secondary

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iyengar Yoga Therapy
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Dysmenorrhea

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The inclusion criteria for the proposed study is any menstruating female with dysmenorrhea, endometriosis, or any menstrual disorder. (Ages 12-65)

Exclusion Criteria:

  • The exclusion criteria any one who has not reached menarche (age of menstruation) or who has reached menopause (no longer menstruates). This age range of exclusion is roughly defined as anyone younger than 12 and older than 65. Pregnant individuals are not eligible to participate in this study.

Sites / Locations

  • Iyengar Yoga CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Patients in the intervention group will first undergo 3 months of regular care and then 3 months of biweekly yoga classes. Participants will complete surveys at baseline, 3 months (after of control care), 6 months (after 3 months of biweekly yoga classes), and 12 months (after 6 months of observation and optional yoga practice).

The study lasts 12 months for the intervention and 9 months for the control group with an optional 3 month yoga therapy session offered at the end

Outcomes

Primary Outcome Measures

NIH PROMIS Pain Interference Survey
This survey is a 4 question short form. The PROMIS(r) Pain Interference instruments (adult and child) measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
NIH PROMIS Pain Intensity Survey
This survey is a 3 question short form. The PROMIS Pain Intensity instrument assesses how much a person hurts.
NIH PROMIS Fatigue Survey
This survey is a 4 question short form. The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles.
NIH PROMIS Physical Function Survey
This survey is a 4 question short form. Physical Function measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands.
NIH PROMIS Global Health Scale
This survey is a 7 question short form. The PROMIS Global Health measures assess an individual's physical, mental, and social health.
Self-Reported Home Practice survey
This survey is a 10 question survey about participants home yoga practice.
Menstrual Distress Questionnaire
The Menstrual Distress Questionnaire (MDQ) is a standard method for measuring cyclical perimenstrual symptoms. It is used to help clinicians and researchers make systematic, empirical evaluations of a woman's symptoms, of treatments, and of etiological theories. The MDQ is a 46-item self-report inventory for use in the assessment and treatment of premenstrual and menstrual symptoms.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2018
Last Updated
December 20, 2018
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT03784976
Brief Title
Iyengar Yoga Therapy for Dysmenorrhea and Endometriosis
Official Title
Iyengar Yoga for Treatment of Endometriosis and Secondary Dysmenorrhea: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
July 2, 2021 (Anticipated)
Study Completion Date
July 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this clinical trial is to look at the effectiveness of prescribing yoga classes to patients with dysmenorrhea (irregular or painful periods), or other menstrual disorders on patients' self reported pain and quality of life. Patients will be recruited from primary care clinics around Illinois, including Carle Hospital. This is a randomized trial in which patients will first be randomized into the control or intervention group. Patients in the control group will undergo usual care and be surveyed at baseline, 3 months, 6 months and 9 months. Patients in the control group will be offered the 3 months of yoga therapy complimentary after completing the 9 month control. Control patients who choose to participate in the yoga therapy will be asked to also complete the surveys at the end of the 3 month yoga intervention. Patients in the intervention group will first undergo 3 months of regular care and then 3 months of biweekly yoga classes. Participants will complete surveys at baseline, 3 months (after of control care), 6 months (after 3 months of biweekly yoga classes), 9 months, and 12 months (after 6 months of observation and optional yoga practice).
Detailed Description
Participants will contact the research team with the information on the flyer. Participants will be asked to come to the Iyengar Yoga Center (407 W Springfield Ave, Urbana, IL 61801) to receive more information. Participants will need to disclose their diagnosis to the research staff. If they are not aware of what their diagnosis is, they will need to contact their physician to get their official diagnosis. For example, a woman with dysmenorrhea may be diagnosed with poly cystic ovarian disease or endometriosis or idiopathic dysmenorrhea, or another reproductive disease; participants will need to know their specific diagnosis or find out their specific diagnosis and report it to the research staff. Participants can do this by calling their physicians. For participants that are unaware of their diagnosis, they may also request a copy of their medical records. These records may be shared with the research staff to help determine diagnosis. The research staff will not keep these medical records, but return them to the participants. Participants can then either consent on the first visit or choose to take time as much time as they need and return to the yoga center when they are ready to sign the consent form. Participants will complete the first round of surveys at the yoga center after they sign the consent form (20 minutes). Participants will receive an email or phone call from the study team to inform them of their randomization results. A blind third party statistician will complete the randomization for all participants at the beginning of the study for all 90 participants and will email the study coordinator with the randomization results. Randomization will be done through a free online software called graphpad. (https://www.graphpad.com/quickcalcs/randomize1.cfm). The study lasts 12 months for the intervention and 9 months for the control group with an optional 3 month yoga therapy session offered at the end: Once consented, participants will fill out baseline surveys, and then undergo 3 months of usual care (no intervention), the same baseline surveys will be filled out again, then participants will get biweekly free yoga therapy classes for 3 months, and surveys will again be completed at the end of the intervention. Patients will then have a 6 month follow up and will fill out the surveys one last time. Recruitment will occur on a rolling basis so patients may join the study at anytime and not have to wait for a batched group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Dysmenorrhea, Dysmenorrhea, Dysmenorrhea Secondary, Polycystic Ovary Syndrome, Endometriosis, Fibroid, Menstrual Pain, Menstrual Disorder, Menstrual Discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients in the intervention group will first undergo 3 months of regular care and then 3 months of biweekly yoga classes. Participants will complete surveys at baseline, 3 months (after of control care), 6 months (after 3 months of biweekly yoga classes), and 12 months (after 6 months of observation and optional yoga practice).
Arm Title
Control
Arm Type
No Intervention
Arm Description
The study lasts 12 months for the intervention and 9 months for the control group with an optional 3 month yoga therapy session offered at the end
Intervention Type
Other
Intervention Name(s)
Iyengar Yoga Therapy
Other Intervention Name(s)
Iyengar Yoga
Intervention Description
2 weekly yoga class (1.25 hours each)
Primary Outcome Measure Information:
Title
NIH PROMIS Pain Interference Survey
Description
This survey is a 4 question short form. The PROMIS(r) Pain Interference instruments (adult and child) measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
Time Frame
baseline, 3 months, 6 months, 9 months, 12 months
Title
NIH PROMIS Pain Intensity Survey
Description
This survey is a 3 question short form. The PROMIS Pain Intensity instrument assesses how much a person hurts.
Time Frame
baseline, 3 months, 6 months, 9 months, 12 months
Title
NIH PROMIS Fatigue Survey
Description
This survey is a 4 question short form. The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles.
Time Frame
baseline, 3 months, 6 months, 9 months, 12 months
Title
NIH PROMIS Physical Function Survey
Description
This survey is a 4 question short form. Physical Function measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands.
Time Frame
baseline, 3 months, 6 months, 9 months, 12 months
Title
NIH PROMIS Global Health Scale
Description
This survey is a 7 question short form. The PROMIS Global Health measures assess an individual's physical, mental, and social health.
Time Frame
baseline, 3 months, 6 months, 9 months, 12 months
Title
Self-Reported Home Practice survey
Description
This survey is a 10 question survey about participants home yoga practice.
Time Frame
baseline, 3 months, 6 months, 9 months, 12 months
Title
Menstrual Distress Questionnaire
Description
The Menstrual Distress Questionnaire (MDQ) is a standard method for measuring cyclical perimenstrual symptoms. It is used to help clinicians and researchers make systematic, empirical evaluations of a woman's symptoms, of treatments, and of etiological theories. The MDQ is a 46-item self-report inventory for use in the assessment and treatment of premenstrual and menstrual symptoms.
Time Frame
baseline, 3 months, 6 months, 9 months, 12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Must menstruate or be of menstruating age
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The inclusion criteria for the proposed study is any menstruating female with dysmenorrhea, endometriosis, or any menstrual disorder. (Ages 12-65) Exclusion Criteria: The exclusion criteria any one who has not reached menarche (age of menstruation) or who has reached menopause (no longer menstruates). This age range of exclusion is roughly defined as anyone younger than 12 and older than 65. Pregnant individuals are not eligible to participate in this study.
Facility Information:
Facility Name
Iyengar Yoga Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwen Derk, PhD
Phone
805-797-9496
Email
gderk2@illinois.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Iyengar Yoga Therapy for Dysmenorrhea and Endometriosis

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