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

Primary Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05081869
• Other study ID #: 10840098-772.02-E.60605
• Status: Completed
• Phase: N/A
• Start date: October 30, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: July 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• 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.
• Education Program
There will be video training on the subject for both groups.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Campbell MA, McGrath PJ. Use of medication by adolescents for the management of menstrual discomfort. Arch Pediatr Adolesc Med. 1997 Sep;151(9):905-13. — View Citation

Hasanpour M, Mohammadi MM, Shareinia H. Effects of reflexology on premenstrual syndrome: a systematic review and meta-analysis. Biopsychosoc Med. 2019 Oct 24;13:25. doi: 10.1186/s13030-019-0165-0. eCollection 2019. — View Citation

Hillen TI, Grbavac SL, Johnston PJ, Straton JA, Keogh JM. Primary dysmenorrhea in young Western Australian women: prevalence, impact, and knowledge of treatment. J Adolesc Health. 1999 Jul;25(1):40-5. — View Citation

Kannan P, Claydon LS, Miller D, Chapple CM. Vigorous exercises in the management of primary dysmenorrhea: a feasibility study. Disabil Rehabil. 2015;37(15):1334-9. doi: 10.3109/09638288.2014.962108. Epub 2014 Sep 22. — View Citation

Li R, Li B, Kreher DA, Benjamin AR, Gubbels A, Smith SM. Association between dysmenorrhea and chronic pain: a systematic review and meta-analysis of population-based studies. Am J Obstet Gynecol. 2020 Sep;223(3):350-371. doi: 10.1016/j.ajog.2020.03.002. E — View Citation

Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. Review. — View Citation

Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998 Nov;51(11):903-12. — View Citation

Wosik J, Fudim M, Cameron B, Gellad ZF, Cho A, Phinney D, Curtis S, Roman M, Poon EG, Ferranti J, Katz JN, Tcheng J. Telehealth transformation: COVID-19 and the rise of virtual care. J Am Med Inform Assoc. 2020 Jun 1;27(6):957-962. doi: 10.1093/jamia/ocaa — View Citation

Yonglitthipagon P, Muansiangsai S, Wongkhumngern W, Donpunha W, Chanavirut R, Siritaratiwat W, Mato L, Eungpinichpong W, Janyacharoen T. Effect of yoga on the menstrual pain, physical fitness, and quality of life of young women with primary dysmenorrhea. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sociodemographic Evaluation	A personal data questionnaire was used, in which personal information and information about menstrual periods were questioned.	At the baseline
Primary	Pain Intensity	Visual Analogue Scale was used to measure the pain intensity. The visual analog scale consists of emotional adjectives that mark the level of pain experienced by the person at that moment with a vertical line on the plane. Participants were asked to rate their menstrual pain levels. Each emotion was evaluated between not experiencing that emotion at all (eg, I'm not nervous = 0) and being fully experienced (eg, I'm extremely nervous = 10).	Change from Baseline pain intensity at 8 weeks
Primary	Life Quality	Short Form-36 (SF36) questionnaire, evaluates general health and quality of life. The questionnaire has 36 questions and 8 subscales. Limitations in social activities due to physical health-related limitations, physical pain, general health perceptions, vitality, physical or emotional problems and general mental health are questioned. The answers of the questions are scored between 0 (low) and 100 (high). 0 means the lowest level of life and 100 the highest level of quality of life.	Change from Baseline life quality at 8 weeks
Primary	Menstrual Attitude	The Turkish version of the Menstrual Attitude Scale (MBI) consisting of 5 subscales and a total of 33 items was used to determine the attitudes and behaviors of women during the menstrual period.It was prepared in 1980, based on the view that attitudes about menstruation can be positive as well as negative, and expectations about physiological and emotional symptoms before or during menstruation can be effective in behaviors displayed during this period. Menstruation as a debilitating phenomenon (12 items); Menstruation as a disturbing phenomenon (6 items); Menstruation as a natural phenomenon (5 items); It is a scale consisting of 5 categories and 33 sub-items, including recognizing / anticipating that menstruation will occur (5 items) and denial of the effects of menstruation (7 items). Each item is scored between 1 (strongly disagree) and 5 (totally agree). The high scores obtained from the subscales in the Menstruation Attitude Scale indicate that the attitude towards menstruation	Change from Baseline menstrual attitude at 8 weeks
Primary	Body Awareness	Participants; The Body Awareness Questionnaire, which was developed by Shields et al. In 1989, was used to define body awareness, evaluate the effectiveness of the treatment, and determine its relationship with physical and emotional components. Body Awareness Questionnaire is defined as a tool with psychometric features that fully evaluates the concept of body awareness. It consists of 18 questions in total. Each question is scored between 1 (Not right at all for me) to 7 (Totally true for me). A high score in the questionnaire means high body awareness.	Change from Baseline body awareness at 8 weeks
Primary	Satisfaction survey	Three questions about the satisfaction of the online exercise program applied at the end of the study were asked to the participants in the study group. Satisfaction with the treatment and the level of recommending the treatment to other patients were asked to be scored between 0 and 10, and if they had a choice, they were asked whether they would prefer an online or a face-to-face exercise program.	At the end of the 8 weeks
Primary	Weight	kg	At the baseline
Primary	Height	m	At the baseline

External Links

•   Coronavirus disease (COVID-19) pandemic/Vaccines, treatment & tests
•   Effects of reflexology on premenstrual syndrome: a systematic review and meta-analysis
•   International Statistical Classification of Diseases and Related Health Problems 10th Revision
•   Public health matters