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

Официальное название

The Effect of Telerehabilitation-Based Cognitive Exercise Therapy Approach and Yoga on Pain, Physical Function and Quality of Life in Adolescents With Dysmenorrhoea

Обзор

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.

Подробное описание

This study was designed as a prospective, randomised, controlled, parallel group study.

G-Power Statistical and Qualitative Data Analysis Software version 3.1.9.2 will be used to estimate the sample size required for the study. Considering that the study consists of a total of three parallel groups (cognitive exercise therapy approach, yoga, control) with measurements taken at three different time points, and given an effect size of Cohen's f = 0.25 and a significance level (α) of 0.05, and power (1-β error level) of 0.80, the total sample size is planned to be 36 cases, with a minimum of 12 cases per group. Considering a potential follow-up loss rate of 20%, it is estimated that at least 42 participants should be included in the study.

In similar studies in the literature, the effect size observed in menstrual pain levels is very large. Considering that the effect size may be more moderate in real life and in order to increase the publishability of the research findings, the effect size was set to Cohen's f = 0.25 and the sample size calculation was performed.

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 reveal the effectiveness of the applications, reduce bias, and ensure homogeneity between the training and control groups, the distribution of groups will be determined randomly using a computer program.

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.

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.

Вмешательства

• Другое Cognitive Exercise Therapy Approach
  It 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).
• Другое Yoga
  It 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).
• Другое Routine Medical Treatment
  Assessments of individuals in this group will be made face-to-face in the relevant clinic.

Первичные конечные точки

• Pain intensity (VAS) [Срок оценки: Pain intensity will be assessed 2 days before, 1 day before, on the 1st, 2nd and 3rd day of menstruation.]
• Physical function (Flexibility) [Срок оценки: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.]
• Physical function (Peripheral muscle strength) [Срок оценки: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.]
• Physical function (Respiratory Function) [Срок оценки: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.]
• Physical function (Heart Rate Variability) [Срок оценки: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.]
• Adolescent quality of life [Срок оценки: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.]

Вторичные конечные точки (5)

• Education absenteeism [Срок оценки: It will be done twice: before the treatment and at the 12th week after the treatment.]
• Depression, anxiety, stress level [Срок оценки: It will be done 3 times: before the treatment and 12 weeks after the treatment.]
• Dysmenorrhea Impact [Срок оценки: It will be done 3 times: before the treatment and 12 weeks after the treatment.]
• Physical activity [Срок оценки: It will be done 3 times: before the treatment and 12 weeks after the treatment.]
• Patient satisfaction [Срок оценки: It will be done twice: before the treatment and at the 12th week after the treatment.]

Критерии участия

Критерии включения

• 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),
• Nulliparous (having never given birth),
• Able to read and write in Turkish,
• Willing to participate in the study and having provided informed consent.

Критерии исключения

• 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,
• Use of intrauterine devices (IUDs),
• Having participated in a regular exercise, sports, or physiotherapy program within the last 6 months,
• Concurrent participation in another clinical study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Acibadem Mehmet Ali Aydinlar University — Istanbul

Публикации

• Gutman G, Nunez AT, Fisher M. Dysmenorrhea in adolescents. Curr Probl Pediatr Adolesc Health Care. 2022 May;52(5):101186. doi: 10.1016/j.cppeds.2022.101186. Epub 2022 May 4. PMID 35523674
• Unnisa H, Annam P, Gubba NC, Begum A, Thatikonda K. Assessment of quality of life and effect of non-pharmacological management in dysmenorrhea. Ann Med Surg (Lond). 2022 Aug 30;81:104407. doi: 10.1016/j.amsu.2022.104407. eCollection 2022 Sep. PMID 36147090
• De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20. PMID 26841639
• Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096. PMID 33030880
• 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. J Bodyw Mov Ther. 2017 Oct;21(4):840-846. doi: 10.1016/j.jbmt.2017.01.014. Epub 2017 Feb 7. PMID 29037637
• Kirca N, Celik AS. The effect of yoga on pain level in primary dysmenorrhea. Health Care Women Int. 2023 May;44(5):601-620. doi: 10.1080/07399332.2021.1958818. Epub 2021 Sep 17. PMID 34534030
• Rakhshaee Z. Effect of three yoga poses (cobra, cat and fish poses) in women with primary dysmenorrhea: a randomized clinical trial. J Pediatr Adolesc Gynecol. 2011 Aug;24(4):192-6. doi: 10.1016/j.jpag.2011.01.059. Epub 2011 Apr 21. PMID 21514190
• Yang NY, Kim SD. Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Trial. J Altern Complement Med. 2016 Sep;22(9):732-8. doi: 10.1089/acm.2016.0058. Epub 2016 Jun 17. PMID 27315239

Идентификаторы

NCT: NCT06398990 · 2024-1/35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗