Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea

NCT ID: NCT05081869

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-30
• Study Completion Date: 2022-01-30

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Online Yoga Based Exercise Program

A 50-minute online exercise program consisting of 5 categories will be created. The program will last 8 weeks, twice a week. In the first category, 20-30 seconds of stretching was applied to iliopsoas, hamstring, adductor, tensor fascia lata, piriformis, quadratus lumborum, quadriceps femoris and gastrocnemius muscles. In the second category, stabilization and pelvic mobilization exercises will be applied to the core muscles. Each exercise will be performed in 3 sets of 10 repetitions. In the third category, strengthening exercises will be done for the gluteal muscles, abdominal muscles, erector spine, quadriceps femoris and latissimus dorsi. Each exercise will be performed as 10 repetitions and 3 sets. In the fourth category, 3 sets and 10 repetitions of kegel exercises will be done. minute diaphragmatic breathing will be applied.

Group Type: EXPERIMENTAL

Exercise Program

Intervention Type: OTHER

An online yoga-based exercise program will be applied for 16 sessions in individuals' own environments. The exercise program will consist of stretching, mobilization, stabilization, strengthening and relaxation exercises.

Education Program

Intervention Type: OTHER

There will be video training on the subject for both groups.

Education Program

The informative training was given to both group members individually and online. In the training program; The female reproductive system organs, the structure of the pelvis, the location and functions of the pelvic floor muscles, the definition and physiology of menstruation, the types and risk factors of dysmenorrhea, the definition and symptoms of primary dysmenorrhea, treatment methods for coping with pain in primary dysmenorrhea were mentioned.

Group Type: SHAM_COMPARATOR

Education Program

Intervention Type: OTHER

There will be video training on the subject for both groups.

Interventions

Exercise Program

An online yoga-based exercise program will be applied for 16 sessions in individuals' own environments. The exercise program will consist of stretching, mobilization, stabilization, strengthening and relaxation exercises.

Intervention Type: OTHER

Education Program

There will be video training on the subject for both groups.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

yaren cakmak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaren Çakmak

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medipol University Hospital

Locations

Istanbul Medipol University Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Related Links

http://bpsmedicine.biomedcentral.com/articles/10.1186/s13030-019-0165-0

Effects of reflexology on premenstrual syndrome: a systematic review and meta-analysis

http://www.who.int/emergencies/diseases/novel-coronavirus-2019

Coronavirus disease (COVID-19) pandemic/Vaccines, treatment \& tests

http://publichealthmatters.blog.gov.uk/

Public health matters

Other Identifiers

10840098-772.02-E.60605

Identifier Type: -

Identifier Source: org_study_id