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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06398990
Study type Interventional
Source Acibadem University
Contact Dilek Çagri Arslan, Res. Asst.
Phone +902165004182
Email Dilek.Cagri@acibadem.edu.tr
Status Not yet recruiting
Phase N/A
Start date October 2024
Completion date December 2026

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