Clinical trial NCT05081869: Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea
Official title: Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Yoga
Telerehabilitation
Exercise
Online
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty women with primary dysmenorrhea will be divided into two groups as study and control. The working group will be subjected to informative training and an online exercise program of 16 sessions. The control group will only receive information training.
Primary purpose: TREATMENT

Brief summary: Dysmenorrhea; It is defined as painful menstrual bleeding and is included in the 10th Revision of International Disease Statistics and Related Health Problems published by the World Health Organization in 1992. In women with dysmenorrhea, pain usually begins within 1-2 years after menarche, is intermittent, cramp-like, predominantly in the suprapubic region, and may sometimes be accompanied by various symptoms such as diarrhea, nausea, and vomiting. The incidence of dysmenorrhea can often differ because most women suffering from this problem do not seek any health care services. Symptoms of the menstrual period may negatively affect women in all areas of life by causing various somatic and psychological problems. The state of being absent at least once at school or work due to symptoms of primary dysmenorrhea has been reported by 13-51% of women suffering from this condition. In the treatment of dysmenorrhea, the application of exercise to reduce the level of pain and alleviate the severity of symptoms was started by Mosler in 1914. Mosler demonstrated that exercise pumps blood to the uterus, thereby reducing menstrual pain. In later recent studies, it was found that exercise increases beta-endorphin hormone secretion, which has a natural pain reliever effect in the body; suggested that it reduces stress, pain, and prostaglandin levels. Therefore, the use of exercise as a therapy is thought to improve not only pain and mental health symptoms, but also the quality of life. As of March 11, 2020, since the World Health Organization defined Coronavirus Disease 2019 (COVID-19) as a pandemic. In the current epidemic process, the concept of "social distance" has been emphasized as the most important and basic way of reducing the risk of transmission from close contact, and the importance of choosing telerehabilitation has been emphasized once again. Online application of exercise programs can be defined as telerehabilitation, as the transmission of rehabilitation services over long distances by using electronic information and communication technology. In recent years, it has become one of the popular areas with the development of technology. Due to the limited number of studies on this subject in the literature, our study aimed to investigate the effect of the online yoga-based exercise program on women with primary dysmenorrhea.

Detailed description: This study will be conducted online between March 2021 and May 2021 in their own settings for women with regular menstrual cycles to investigate the impact of online yoga-based exercise programs on women with primary dysmenorrhea. All participants will be given detailed information about the study and a written informed consent form will be signed that they agree to work voluntarily. The GPower program was used to determine the number of people to be included in the study and control groups. When the results of two studies similar to our study were evaluated in the literature review, it was seen that the Effect size d value for the VAS score was distributed between 0.17 and 2.06 and clustered around 1. When the effect size was d = 1, α = 0.05, Power (1-β) = 0.90 (90%) was taken in the GPower package program, and the minimum sample size was determined to be 50, 25 in the study and control groups. They will be randomly divided into two groups of 25 people each, according to the order of application. While an online yoga-based exercise program and an informative training program was applied to the experimental group from two randomly separated groups, only an informative training program will be given to the control group.

Eligibility criteria: Inclusion Criteria:

* Being a nulliparous woman between the ages of 18-35,
* Having a primary dysmenorrhea symptom,
* Having a regular menstrual cycle (28 ± 7 days),
* Menstrual pain Visual Analogue Scale score higher than 4 cm in the last 6 months

Exclusion Criteria:

* Having gastrointestinal, urogynecological, autoimmune, psychiatric, neurological diseases or other chronic pain syndromes,
* To have given birth, Current pregnancy status,
* Using an intrauterine device and having had pelvic surgery,
* Using drugs including oral contraceptives or antidepressants at least 6 months before the study,
* Having an irregular menstrual cycle (those with a menstrual cycle shorter than 21 days or longer than 35 days)
* A pathological history or ultrasonographic result showing secondary dysmenorrhea.

Primary outcomes:
measure: Sociodemographic Evaluation
timeFrame: At the baseline
measure: Pain Intensity
timeFrame: Change from Baseline pain intensity at 8 weeks
measure: Life Quality
timeFrame: Change from Baseline life quality at 8 weeks
measure: Menstrual Attitude
timeFrame: Change from Baseline menstrual attitude at 8 weeks
measure: Body Awareness
timeFrame: Change from Baseline body awareness at 8 weeks
measure: Satisfaction survey
timeFrame: At the end of the 8 weeks
measure: Weight
timeFrame: At the baseline
measure: Height
timeFrame: At the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
Study officials:
affiliation: Istanbul Medipol University Hospital
name: Yaren Çakmak
role: PRINCIPAL_INVESTIGATOR
References:
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