- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07000487
- Original Trial
Effect of Yoga Training on Nausea and Pain
Effect of Yoga Training on Nausea and Pain Symptoms in Young Women With Primary Dysmenorrhea: A Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary dysmenorrhea (PD) is one of the most common gynecological conditions affecting an estimated 67% to 90% of young women and is a painful uterine contraction caused by endometrial laceration . PD is also known as painful periods or menstrual cramps that cause pain during the menstrual cycle. Menstrual pain is the most common symptom associated with primary dysmenorrhea. The pathogenesis of menstrual pain is thought to be due to an abnormal increase in the production of vasoactive prostaglandins in the endometrium, which can induce myometrial hyperactivity, uterine tissue ischemia, and pain. The pain caused by dysmenorrhea begins a few days before menstruation and lasts for 48-72 hours. The pain is usually in the pelvis or lower abdomen and may radiate to the lower back and upper thighs. Other symptoms that the individual may experience include diarrhea, headache, stress, and nausea.
Yoga is one of the self-development and exercise methods that fully trains the soul, mind and body and allows the individual to know themselves. Yoga, which is a mental journey that the individual makes to their inner world, is a technique that allows the person to be alone with themselves as a result of the combination of physical posture, breathing techniques and mental meditation. The yoga-based lifestyle includes positive behavioral changes (yamas and niyamas), physical posture practices (asanas), breathing regulation (pranayama), control of the senses (pratyahara) and meditation techniques (dharana, dhyana and samadhi). It has been determined in the literature that yoga reduces menstrual cramps and distress, and it has been reported that it can be used in menstrual problems due to its safety, lack of side effects, low cost, easy accessibility and noninvasiveness. Previous studies report that yoga suppresses menstrual pain by reducing the level of prostaglandin production and myometrial ischemia through "down-regulation of the hypothalamic-pituitary-adrenal axis and the sympathetic nervous system" and has positive effects on psychological well-being. In addition, studies have determined that yoga is also effective in nausea and vomiting symptoms. In a systematic review conducted on individuals with cancer, it was determined that yoga is effective in symptom management (nausea and vomiting, fatigue, anxiety, depression, etc.). The aim of this study is to determine the effect of yoga training in reducing nausea and pain symptoms in young women with primary dysmenorrhea. The results of the study will contribute to the literature on dysmenorrhea, one of the important gynecological problems in women. In addition, although there are many results in the literature on the effectiveness of yoga in the management of nausea and vomiting symptoms with cancer patients, no study on dysmenorrhea has been found. In this respect, it will also provide important evidence to the literature.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sakine Yılmaz
- Phone Number: 05439380626
- Email: sakinee_yilmaz@hotmail.com
Study Locations
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-
None Selected
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Cankiri, None Selected, Turkey, 18100
- Çankırı
-
Contact:
- Sakine Yılmaz, Assistant Professor Doctor
- Phone Number: +905439380626
- Email: sakinee_yilmaz@hotmail.com
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Principal Investigator:
- Sakine Yılmaz, Assistant Professor Doctor
-
Sub-Investigator:
- Demet Aktaş, Associate Professor
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Sub-Investigator:
- Nilay Gökbulut, Assistant Professor Doctor
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Sub-Investigator:
- Ebru Yıldırım, Research Assistant
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a regular menstrual cycle
- Being single
- Not having any psychiatric diagnosis or gynecological disease (abnormal uterine bleeding, myoma, ovarian cysts, etc.) extremities and any health problems that may prevent physical exercise
- Not having any systemic disease (heart, diabetes, epilepsy, rheumatoid arthritis, etc.)
- Young women who agree to participate in the study and can speak and understand Turkish
Exclusion Criteria:
- Wanting to leave the study, primary dysmenorrhea severity and nausea level below 4 points.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental:Yoga
Hatha yoga will be applied in this study.
Yoga practice will be carried out by the researcher for 6 weeks, 1 day face-to-face and 1 day online, and each practice will be 60 minutes, in total 12 sessions, considering the studies done.
It will be applied by a researcher with a yoga certificate.
Pre-test and post-test nausea and pain measurements will be made.
|
Hatha yoga will be applied in this study.
Yoga practice will be carried out by the researcher for 6 weeks, 1 day face-to-face and 1 day online, and each practice will be 60 minutes, in total 12 sessions, considering the studies done.
It will be applied by a researcher with a yoga certificate.
Pre-test and post-test nausea and pain measurements will be made.
|
|
No Intervention: No Intervention: Control Group
No application will be made to this group by the researcher.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Before and 6 weeks after yoga practice
|
VAS is a suitable measurement tool for the assessment of acute pain.
This scale is used to convert some values that cannot be measured numerically.
0 means "No pain" and 10 means "Worst possible pain".
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Before and 6 weeks after yoga practice
|
|
Visual Analog Scale (VAS)
Time Frame: Before and 6 weeks after yoga practice
|
VAS will be used to assess nausea.The scale consists of a horizontal line 100 mm/10 cm long.
At the left end of the line is 0 "No nausea", while at the right end is 10 "Severe nausea".
The individual is asked to mark the point on the line that will accurately reflect their nausea.
The distance of the individual's mark to the left end is measured with a ruler.
This distance, measured in millimeters, is accepted as a "score" and recorded.
In selecting individuals, values of 5 mm and below on the scale are evaluated as "no nausea", and all values of 5 mm and above are evaluated as "experiencing nausea".
|
Before and 6 weeks after yoga practice
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Primary dysmenorrhea
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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