Secondary DysmenorrheaNCT03784976
Iyengar Yoga Therapy for Dysmenorrhea and Endometriosis
A study testing Iyengar Yoga Therapy in people with Secondary Dysmenorrhea and Dysmenorrhea, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years, women only
- Conditions the study is for
- Secondary Dysmenorrhea, Dysmenorrhea, Dysmenorrhea Secondary
- What is being tested?
- Iyengar Yoga Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2018to 2 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria for the proposed study is any menstruating female with dysmenorrhea, endometriosis, or any menstrual disorder. (Ages 12-65)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Iyengar Yoga Center
Urbana, Illinois, 61801
Gwen Derk, PhD, 805-797-9496, gderk2@illinois.edu
About this study
Official title: Iyengar Yoga for Treatment of Endometriosis and Secondary Dysmenorrhea: A Randomized Controlled Clinical Trial
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).
Read the 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.
- Conditions
- Secondary Dysmenorrhea, Dysmenorrhea, Dysmenorrhea Secondary, Polycystic Ovary Syndrome, Endometriosis, Fibroid
- Being tested
- Iyengar Yoga Therapy
- Medical subject headings
- Dysmenorrhea, Polycystic Ovary Syndrome, Endometriosis, Leiomyoma, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar Yoga TherapyOther
Also called Iyengar Yoga
2 weekly yoga class (1.25 hours each)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Other: Iyengar Yoga Therapy |
| Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months, 6 months, 9 months, 12 months
NIH PROMIS Pain Intensity Survey
This survey is a 3 question short form. The PROMIS Pain Intensity instrument assesses how much a person hurts.
Measured: baseline, 3 months, 6 months, 9 months, 12 months
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.
Measured: baseline, 3 months, 6 months, 9 months, 12 months
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.
Measured: baseline, 3 months, 6 months, 9 months, 12 months
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.
Measured: baseline, 3 months, 6 months, 9 months, 12 months
Self-Reported Home Practice survey
This survey is a 10 question survey about participants home yoga practice.
Measured: baseline, 3 months, 6 months, 9 months, 12 months
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.
Measured: baseline, 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start3 Jul 2018
- Primary completion2 Jul 2021 (estimated)
- Study completion2 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kashif Ahmad, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784976
- Sponsor's protocol ID
- 18257
- Status last verified
- Dec 2018
- First submitted
- 11 Sep 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iyengar Yoga for Treatment of Endometriosis and Secondary Dysmenorrhea: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03784976
- Acronym / sponsor ID
- 18257
- Conditions
- Secondary Dysmenorrhea, Dysmenorrhea, Dysmenorrhea Secondary, Polycystic Ovary Syndrome, Endometriosis, Fibroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 2 Jul 2021 (estimated)
- Study completion
- 2 Jul 2021 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Iyengar Yoga TherapyPatients 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). |
| Control | No intervention | –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 |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria for the proposed study is any menstruating female with dysmenorrhea, endometriosis, or any menstrual disorder. (Ages 12-65)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iyengar Yoga TherapyAlso: Iyengar Yoga2 weekly yoga class (1.25 hours each) | Other | Intervention |
Primary outcome
NIH PROMIS Pain Interference Survey
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
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
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
This survey is a 3 question short form. The PROMIS Pain Intensity instrument assesses how much a person hurts.
NIH PROMIS Fatigue Survey
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
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
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
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
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
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
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
This survey is a 10 question survey about participants home yoga practice.
Menstrual Distress Questionnaire
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Yes
Related trials for Secondary Dysmenorrhea
Not yet recruiting
Menstrual Pain Intervention Among Students
Dysmenorrhea, Dysmenorrhea Primary
Recruiting
Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis
Dysmenorrhea, Adenomyosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar Yoga Therapy in people with Secondary Dysmenorrhea and Dysmenorrhea, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH PROMIS Pain Interference Survey (time frame: baseline, 3 months, 6 months, 9 months, 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.