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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05396976
Other study ID # ETK00-2022-0100
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date August 7, 2022

Study information

Verified date May 2022
Source Eastern Mediterranean University
Contact Arzu Abic
Phone 05488506060
Email arzu.abic@emu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Despite the conclusion that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.


Description:

Menstrual cycle is defined as hormonal and physical changes that continue from menarche to menopause, affecting the whole organism, especially the reproductive organs. During this period, which is necessary for the normal continuation of female reproductive functions and occurs periodically every month, women encounter many menstrual problems. Premenstrual syndrome (PMS), one of the most common problems, is defined as the changes that are associated with the luteal phase of the menstrual cycle and that affect a woman's life in a regular and cyclical way, physically, emotionally and behaviorally.It is stated that PMS, which is very common in the society, affects close family relations, social life, work performance and work relations. The most common symptoms are; muscle, stomach and headache, breast tenderness, weight gain, intense desire for certain foods, appetite change, acne, edema, fatigue, mood swings, emotionality, irritability. It is known that the mental health of women who are physiologically affected by PMS will also be affected by the syndrome and bring along mental problems. Schmelzer stated in his study that the emergence of depressive thoughts and emotions in the premenstrual period is one of the most common PMS symptoms. In many studies examining the relationship between mental health and PMS, it has been found that there is a positive and significant relationship between PMS and depression level. One of these studies, Uran et al., in a study conducted with 55 people with an average age of 15, stated that the most common psychological factors accompanying PMS were irritability and anger level. As can be seen, PMS has negative effects on both mental health and physical health. Although many areas of women with PMS are negatively affected in their daily lives and its incidence is high, very few of them receive professional help and medical care. At the same time, their quality of life is also declining. It is known that women often resort to non-pharmacological methods instead of receiving professional health care, since PMS is considered to be a physiologically normal condition with a traditional point of view.In addition, undesirable effects of medical treatments in coping with PMS are not preferred by women because they bring many health risks. Women can use many non-invasive and risk-free integrated treatment methods (such as heat treatments, exercise, aromatherapy, phytotherapy, Transcutaneous Electrical Nerve Stimulation, acupuncture, acupressure, yoga, progressive relaxation exercises, massage, relaxation techniques, reflexology, reiki) in coping with PMS. ) are more oriented. One of these methods, yoga, is a practice that includes deep breathing, meditation, stretching exercises and posture poses based on the unity of mind and body. It is emphasized that yoga exercises reverse the negative effects of stress on the immune system, improve inflammatory processes, reduce symptoms such as pain and insomnia, and improve quality of life, thanks to the balance, stretching, relaxation and strengthening components.In Yang and Kim's study with undergraduate nursing students with primary dysmenorrhea, a 60-minute yoga program was applied once a week for 12 weeks. As a result of the study, it was determined that menstrual pain decreased significantly in the intervention group compared to the control group. Yonglitthipagon et al. found that yoga exercise applied to women with primary dysmenorrhea between the ages of 18-22 for 30 minutes twice a week for 12 weeks reduced menstrual pain and increased physical fitness and quality of life. It has also been reported in studies that progressive relaxation exercises have a reducing effect on depression, stress and anxiety. Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Although it is concluded that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date August 7, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: Filling the data collection tools and not having an obstacle that would cause communication difficulties in the interviews Having a score of 110 or more from the PMS scale in the data collection form Voluntary consent to participate in the study Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days), Being a second and third year nursing student be over 18 years old Exclusion Criteria: Receiving medical treatment for PMS Being pregnant or having experienced pregnancy before Having a systemic or chronic disease No physical or mental health problems that prevent exercise

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga and Muscle Relaxation Exercise Practices
Yoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.

Locations

Country Name City State
Cyprus Eastern Mediterranean University Famagusta

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Premenstrual Syndrome Scale Premenstrual syndrome scale is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms by Gençdogan (2006). In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option as 2 points, the "Sometimes" option as 3 points, the "Often" option as 4 points, and the "Constantly" option as 5 points. 10 weeks
Primary Depression Anxiety Stress Scale-21 The DASS-21 scale, which is an abbreviated version of DASÖ-42 developed by Lovibond and Lovibond in 1995, was used. The 21-item short form (DASS-21) of the scale was adapted to Turkish by Sariçam in 2018 in normal and clinical samples. The scale is a 4-point Likert-type scale and includes 21 questions in total, 7 questions each to measure the dimensions of depression, anxiety and stress. 10 weeks
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