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The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea

StatusRecruiting
PhaseNot applicable
Started2025-12-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 6 → 1 primary endpoints
See other at-risk trials from Acibadem University

Amendment history

2026-08-25
Study Status, Study Description, Arms and Interventions, Outcome Measures v9
Primary endpoint(s) modified6 to 1 entries
WasAdolescent quality of life, Pain intensity (VAS), Physical function (Flexibility), Physical function (Heart Rate Variability), Physical function (Peripheral muscle strength), Physical function (Respiratory Function)
NowPain intensity (VAS)
Secondary endpoints5 to 15 entries
Physical function (Flexibility) Physical function (Peripheral muscle strength) Physical function (Heart Rate Variability) Adolescent quality of life Menstrual symptom questionnaire Menstrual attitude questionnaire Forced vital capacity (FVC) Forced expiratory volume in 1 second (FEV1) FEV1/FVC ratio [...]
Study description-16 characters
[...] . G-Power Statistical and Qualitative Data Analysis Software version 3.1.9.2 will be used to estimate the sample size required for the s [...]
2026-08-19
Study Status, Study Design, Outcome Measures v8
Enrollment target42→45
Secondary endpointsdetails revised at 5 of 5 entries
2026-08-17
Study Status, Study Description v7
Study descriptionrevised
[...] l follow-up loss rate of 20%, it is estimated that at least 4245 participants should be included in the study. In similar st [...]
2026-06-30
Study Status, Eligibility v6
Eligibility criteria+13 characters
[...] or suspected pregnancy, Use of intrauterine devices (IUDs), CurrentHaving participated in a regular exercise, sports, or recentphysiotherapy participationprogram inwithin cognitivethe exerciselast therapy6 and/or yoga interventionsmonths, Concurrent participation in another clinical study.
2026-06-03
Study Status v5
Re-verified, no change to tracked fields
Show 4 earlier versions
2026-01-29
Not Yet Recruiting→Recruiting Study Status, Oversight, Study Description, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08→confirmed 2025-12-01
Enrollment target45→42
Study sites0→1
Eligibility criteria+412 characters
Inclusion Criteria: Being diagnosed with dysmenorrhea by a gynecologist and obstetrician, Being betweenBetween the ages of 10- and 19, BeingHaving ablehad 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 diagno [...] to read and write in Turkish, VolunteeringWilling to participate in the study and having provided informed consent. Exclusion Criteria: BeingHistory [...]
Secondary endpoints5 entries, revised
SchoolEducation performancesabsenteeism
Study description-81 characters
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 v [...] with measurements taken at three different time points, and assuminggiven an effect size of Cohen's f = 0.25, and a significance level (α) of 0.05, and power (1-β error leve [...] anned to be 36 cases, with a minimum of 12 cases per group. AssumingConsidering a potential follow-up loss rate of 20% attrition rate, it is estimated that at lea [...] [...]
2025-08-04
Study Status, Study Description v3
Study description-19 characters
[...] ople receiving routine medical treatment. In order to fully demonstratereveal the effectiveness of the interventionsapplications, to reduce bias, and to ensure homogeneity between the training and control groups, the allocationdistribution to theof groups will be determined inrandomly theusing randomisera orgcomputer program. programme. Yoga and cognitive exercise therapy approach will be applied [...] sly with the patients 2 times a week via the online platform (Zoom). Evaluations will be carried out 3 times as pre-treatment, [...]
2025-07-09
Study Status, Oversight, Study Description, Outcome Measures v2
Start date2025-03-03→2025-08
Primary endpoints5 to 6 entries
Physical function (Heart Rate Variability) Physical function (Respiratory muscle strengthFunction)
Study description+415 characters
[...] ical and Qualitative Data Analysis Software version 3.1.9.2 waswill be used to estimate the sample size required for the study. Considering that the study consistedconsists of a total of three parallel groups to(cognitive beexercise measuredtherapy approach, yoga, control) with measurements taken at three different time points, and theassuming an effect size of Cohen's f = 0.25, α errora significance level (α) of 0.05, and power (1-β error level) of 0.80, the total sample size wasis calculatedplanned asto be 36. When thecases, estimatedwith ratea minimum of subjects12 whocases mightper begroup [...] [...]
2025-01-28
Study Status, Outcome Measures v1
Start date2024-10→2025-03-03
Secondary endpointsdetails revised at 3 of 5 entries
2024-05-01
Original filing
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.
Trial Details
NCT Number NCT06398990
Lead Sponsor Acibadem University
Collaborators: Bezmialem Vakif University
Conditions Dysmenorrhea, Primary Dysmenorrhea
Enrollment 45 participants
Start Date 2025-12-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-27