The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
- Conditions
- Primary DysmenorrheaDysmenorrhea
- Interventions
- Other: YogaOther: Routine Medical TreatmentOther: Cognitive Exercise Therapy Approach
- Registration Number
- NCT06398990
- Lead Sponsor
- Acibadem University
- Brief Summary
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.
- Detailed Description
This study was designed as a prospective, randomised, controlled, parallel group study.
The population of the study consisted of patients who applied to gynaecology and obstetrics specialists in Istanbul.
G-Power Statistical and Qualitative Data Analysis Software version 3.1.9.2 was used to estimate the sample size required for the study. Considering that the study consisted of a total of three parallel groups to be measured at three different time points and the effect size f=0.25, α error level 0.05, power (1-β error level) 0.80, the total sample size was calculated as 36. When the estimated rate of subjects who might be lost to follow-up was taken as 20%, it was calculated that at least 45 subjects should be included in the study.
The 1st intervention group will receive cognitive exercise therapy approach, the 2nd intervention group will receive yoga, and the 3rd control group will consist of people receiving routine medical treatment. In order to fully demonstrate the effectiveness of the interventions, to reduce bias and to ensure homogeneity between the training and control groups, the allocation to the groups will be determined in the randomiser org. programme.
Yoga and cognitive exercise therapy approach will be applied by a physiotherapist who has training in both fields. Treatments will continue twice a week for 12 weeks. After the initial assessment of the cases, one-to-one, face-to-face trainings will be carried out in the first week (2 sessions) in order to ensure their compliance with the treatment and to fully understand the treatment method. Afterwards, treatments will be carried out synchronously with the patients 2 times a week via the online platform (Zoom).
Evaluations will be carried out 3 times as pre-treatment, 6th week and 12th week. All evaluations will be made face-to-face in the relevant clinic.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 45
- Being diagnosed with dysmenorrhea by a gynecologist and obstetrician,
- Being between the ages of 10-19,
- Being able to read and write Turkish,
- Volunteering to participate in the study.
- Being diagnosed with secondary dysmenorrhea,
- Being diagnosed with another gynecological disease,
- Having serious comorbidities (neurological and/or cardiovascular and/or musculoskeletal disorders, psychiatric, gastrointestinal, autoimmune),
- Has a history of surgery involving the abdominal region, pelvic region and spine within the last year,
- Previous experience with yoga and cognitive exercise therapy approaches,
- People who are actively participating in a different study will not be included in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Yoga Programme Yoga Yoga sessions will consist of exercises including various movements in one session and the exercises will be practised with respiratory control, accompanied by a physiotherapist. Routine Medical Treatment Routine Medical Treatment Individuals in this group will receive medical treatment recommended by the relevant physician. Cognitive Exercise Therapy Approach Cognitive Exercise Therapy Approach Cognitive exercise therapy sessions will consist of exercises including various movements in one session and the exercises will be worked with respiratory control, accompanied by a physiotherapist.
- Primary Outcome Measures
Name Time Method Physical function (Flexibility) It will be done 3 times: before the treatment, at the 6th week and at the 12th week. 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).
Pain intensity (VAS) Pain intensity will be assessed 2 days before, 1 day before, on the 1st, 2nd and 3rd day of menstruation. 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 (Respiratory muscle strength) It will be done 3 times: before the treatment, at the 6th week and at the 12th week. Respiratory Muscle Strength: Respiratory muscle strength will be measured according to American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria using an electronic intraoral pressure measurement device (MicroRPM, Micro Medical, England).
Maximal inspiratory pressure (MIP) and Maximal Expiratory Pressure (MEP) measurements of the cases will be made.Adolescent quality of life It will be done 3 times: before the treatment, at the 6th week and at the 12th week. Pediatric Quality of Life Inventory TM (PedsQL)(Adolescent Form): The PedsQL is a quality of life scale that is suitable for use in both healthy and diseased children and adolescents. The PedsQL consists of child and parent forms aged 2-18 years. Since the adolescent group will be included in this study, the 13-18 years old Adolescent Form will be used. Scoring is done in 3 areas. Firstly, the total scale score (TSS), secondly, the total physical health score (PHSS), and thirdly, the total psychosocial health score (TPHSS), which consists of the calculation of item scores evaluating emotional, social and school functionality, are calculated. The items are scored between 0-100. If the answer to the question is marked as never, 100 points are scored; if it is marked as rarely, 75 points are scored; if it is marked as sometimes, 50 points are scored; if it is marked as frequently, 25 points are scored; if it is marked as almost always, 0 points are scored.
Physical function (Peripheral muscle strength) It will be done 3 times: before the treatment, at the 6th week and at the 12th week. 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.
- Secondary Outcome Measures
Name Time Method School performances It will be done twice: before the treatment and at the 12th week after the treatment. Adolescent cases with dysmenorrhea are usually of school age and cannot attend school for a few days due to the dysmenorrhea they experience during their menstrual periods, and this affects their school performance. For this reason, the school performance of the subjects who will participate in the study will be evaluated with the course notes taken from their parents. Notes taken before and after treatment will be compared.
Depression, anxiety, stress level It will be done 3 times: before the treatment and 12 weeks after the treatment. 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 It will be done 3 times: before the treatment and 12 weeks after the treatment. 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 It will be done 3 times: before the treatment and 12 weeks after the treatment. 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.
Patient satisfaction It will be done twice: before the treatment and at the 12th week after the treatment. The question of whether a patient is improving is fundamental in clinical practice, and the information obtained is important in making decisions regarding prognosis and treatment. Global Rating of Change (GROC) scales are widely used in clinical research, especially in the field of the musculoskeletal system. These scales are a rapid, effective method designed to measure a patient's improvement or worsening over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition.
In our study, to measure treatment satisfaction, "-2" means "I am very bad compared to before treatment", "-1" means "I am worse than before treatment", "0" means there is no change compared to before treatment, "1" means I am better than before treatment, "2" means I am very better than before treatment. The Global Rating of Change (GROC) scale will be used in the five-point Likert system.