About this trial
Dysmenorrhoea is a condition that negatively affects the quality of life in women of many age groups. In girls with dysmenorrhoea in adolescence, there is an effect on school performance, self-confidence-depression problems and a decrease in quality of life due to pain. In order to eliminate these negative effects, they should receive a good treatment. Medical treatment usually tries to minimise and balance this situation. Considering the fact that families do not want to use drugs such as oral contraceptives in their children at this age and the risks of oral contraceptives, parents are in different searches. Considering that the approach to pain should always be from a holistic perspective, yoga and cognitive exercise therapy approaches are both biopsychosocial treatment methods within the scope of mind-body integrity. Yoga and cognitive exercise therapy approach is thought to reduce symptoms, improve physical functions and quality of life in adolescent girls. With these positive effects, school absenteeism decreases, depression and self-confidence improve. Health costs will also be reduced to some extent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 10 and 19,
Having had a menstrual cycle for at least 6-12 months (ACOG, 2018),
Having menstrual pain intensity of ≥4 cm according to the Visual Analog Scale (VAS, 0-10 cm) (Kannan, P. 2015; Yonglitthipagon, P. 2017),
To have been diagnosed with primary dysmenorrhea according to the clinical characteristics and diagnostic approach defined in international dysmenorrhea guidelines (ACOG 2018; JOGC 2017),
Disqualifiers
History or clinical findings suggestive of secondary dysmenorrhea,
Presence of serious comorbidities, including neurological, cardiovascular, musculoskeletal, psychiatric, gastrointestinal, or autoimmune disorders,
History of surgery involving the abdominal, pelvic, or spinal regions within the past 12 months,
Current pregnancy or suspected pregnancy,
Trial design
Parallel
Treatments tested in this trial
Cognitive Exercise Therapy Approach
Other interventionIt will continue twice a week for 12 weeks. After the initial evaluation of the cases, one-on-one, face-to-face training will be provided with the patient in the first week (2 sessions) in order to ensure their compliance with the treatment and to fully understand the treatment method. Then, treatments will be carried out synchronously with the patients twice a week via the online platform (Zoom).
Yoga
Other interventionIt will continue twice a week for 12 weeks. After the initial evaluation of the cases, one-on-one, face-to-face training will be provided with the patient in the first week (2 sessions) in order to ensure their compliance with the treatment and to fully understand the treatment method. Then, treatments will be carried out synchronously with the patients twice a week via the online platform (Zoom).
Routine Medical Treatment
Other interventionAssessments of individuals in this group will be made face-to-face in the relevant clinic.
Treatment groups
Trial outcomes
Primary outcomes
Pain intensity (VAS)
In the 10 cm VAS, which is the most widely used, reliable and valid scale in the evaluation of pain intensity all over the world, the left end of the line will be formed as "0 = no pain" and the other end as "10 = unbearable pain". The subjects will be given paper in the form of a pain diary to mark during their menstrual periods and will be asked to mark the point appropriate to the intensity of pain 2 days before, 1 day before, on the 1st, 2nd and 3rd day of menstruation.
Physical function (Flexibility)
Sit-Reach Test: The flexibility of the subjects participating in the study will be evaluated with a standard sit-and-reach box (Sit and Reach Trunk Flexibility Assessment Testing Box, Baseline, NY, USA).
Physical function (Peripheral muscle strength)
Peripheral Muscle Strength: To evaluate the peripheral muscle strength of the subjects, hip flexors, hip extensors and hip abductors will be evaluated with a hand-held dynamometer in both legs.
Physical function (Heart Rate Variability)
Heart Rate Variability: Heart rate variability (HRV) defines the autonomic modulation of heart rate. It reflects parasympathetic activity and sympathetic/parasympathetic nervous system balance. Neuroimaging studies have shown that nociceptive stimulation is closely related to autonomic nervous system activity. Pain can cause a decrease in parasympathetic activity, an increase in sympathetic activity, and sympathovagal imbalance. Autonomic nervous system imbalance caused by sympathetic overactivity may be another cause of primary dysmenorrhea. In response to changes in the external environment, the ANS maintains homeostasis of the internal environment of the human body through the interaction between the sympathetic and parasympathetic nerves. A lack of coordination between the two systems can cause various symptoms. For these reasons, heart rate variability will be measured and recorded in adolescent girls with primary dysmenorrhea using the Polar H10 device.
Secondary outcomes
Education absenteeism
Adolescents with dysmenorrhea are typically of school age and may miss several days of school due to dysmenorrhea experienced during their menstrual periods. Therefore, the school absences of participants in the study will be monitored throughout the process. School absence rates before and after treatment will be compared.
Depression, anxiety, stress level
Depression-Anxiety-Stress Scale Short Form (DASS-21): Both the original 42-item version of the DASS and the shorter 21-item version have been shown to be reliable and valid scales for measuring depression, anxiety and stress levels, through studies conducted with clinical groups, society and different cultural and ethnic groups. 7 items of DASS-21 include questions about depression, 7 items about anxiety, and 7 items about stress. Each subscale (depression, anxiety, stress) has a minimum of 0 and a maximum of 21 points. A low score indicates a good psychological state.
Dysmenorrhea Impact
Revised Dysmenorrhea Impact Scale-Short Form (DIS-R): This 13-item scale, which includes cognitive/emotional (8 items) and physiological (5 items) subscales, has been shown to be a valid and reliable measurement tool. The minimum score on the scale is 0 and the maximum score is 65. As the scores increase, the functional and emotional impact level of individuals with dysmenorrhea also increases.
Physical activity
Physical Activity Questionnaire for Adolescents (PAQ-A): Designed to provide a general estimate of physical activity levels among healthy adolescents, assessing sports participation and activities during and after school, self-administered and based on the last week. Later, a modified form for adolescents was published. The Turkish validity and reliability study of the scale was conducted. 8 questions in the scale are scored between 1 and 5, and the 9th question questions the presence of a condition that prevents physical activity during the last week. A score of '1' corresponds to low-intensity physical activity and a score of '5' corresponds to high-intensity physical activity, but the last question is not included in the scoring. The total score is obtained by calculating the average score of all questions.
Sponsors and contacts
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Acibadem University
Lead sponsor
Bezmialem Vakif University
Collaborator