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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06208670
Other study ID # STogluk
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date August 15, 2024

Study information

Verified date January 2024
Source Siirt University
Contact Bünyamin AVCI
Phone +90 5445084246
Email siirtism@hs01.kep.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Abstract Purpose: This study was conducted to determine the effect of progressive muscle relaxation exercises given to women experiencing premenstrual syndrome on premenstrual syndrome symptoms and tendency to violence. Materials and Methods: The research was planned as an experimental study with a pretest-posttest control group, with female patients coming for examination at Siirt Training and Research Hospital Gynecology Polyclinics between December 2023 and August 2024. "Personal Information Form, Premenstrual Syndrome Scale and Violence Tendency Scale" were used to collect data in the study. Percentage distributions and t-test in independent groups were used to evaluate the data.


Description:

Premenstrual Syndrome (PMS) is defined as a set of physical, psychological, and behavioral symptoms that occur about five days before menstruation and disappear within a few days following its onset (Ryu & Kim, 2015). In a systematic study evaluating data from 17 countries, the prevalence of PMS was 47.8% (Direkvand-Moghadam et al., 2014). In a systematic study conducted to investigate the prevalence of PMS in women of reproductive age in Turkey, the overall prevalence was determined as 52.2%. It was reported that PMS was seen in 59% of high school students, 50.3% of university students, and 66% of the general female population (Erbil & Yücesoy, 2021). Although there are many different symptoms associated with PMS, common physical symptoms include abdominal bloating, weight gain, fatigue, breast tenderness, skin problems, dizziness, and headache or joint pain. Common psychological and behavioral symptoms include mood swings, anger, anxiety, aggression, sad or depressed mood, appetite changes, difficulty concentrating, and decreased interest in activities (Women's Health Concern 2012, Gunderson and Yates 2013; Yonkers & Casper, 2022c). Symptoms related to PMS are reported to cause difficulty in attending school or work, a decline in academic achievement, economic losses, deterioration in interpersonal relationships, social isolation, risk of suicide attempt, substance abuse, and increased tendency to commit crimes or accidents (Borenstein et al., 2003; Yonkers et al., 2008; Tadakawa et al. 2016; Buddhabunyakan et al. 2017, Owens and Eisenlohr-Moul 2018, Abay and Kaplan 2019, Schoep et al. 2019a, 2019b). In addition, the tendency to violence, domestic fights, and child abuse have been reported in women diagnosed with PMS (Halberich, 2007). At the cognitive level, all of the positive thoughts that a person who is ready for violence attributes to violence can be defined as violent tendencies (Karaboğa, 2018). It is known that incidents of violence are increasing in our country, especially among young people (TBMM 2007). On the other hand, violence and aggression are essential problems that are becoming increasingly common all over the world (WHO2002, WHO 2014). The treatment of PMS is usually carried out gradually, including non-pharmacological strategies, pharmacological strategies, including antidepressants or hormonal methods, and surgery (Walsh et al., 2015). PGE, first developed by the American Dr. Jacobson in the 1920s, involves each muscle group's contraction and relaxation, respectively (Liu et al., 2020). During PGE, the major muscle groups are followed in a specific order; this order is hands, arms, eyebrows, eyes, back of neck, front of neck, shoulders, back, chest, abdomen, buttocks, front of thigh, back of thigh, calf and feet (Bushra & Ajaz, 2018; Dhyani et al., 2015; Liu et al., 2020; Perakam et al., 2019). Progressive relaxation exercise is a breathing and stretching method that provides relaxation of nerves and muscles from hand to foot, stimulating the parasympathetic nervous system and reducing sympathetic nervous system activities. In this way, blood pressure, heart and respiratory rate slow down, metabolic rate decreases, endorphin release, pain, and fatigue, and facilitate the transition to sleep (Özer & Ergen, 2010; Kurt & Kapucu, 2018). PGE is among the non-pharmacological methods that nurses can offer caregivers (Yılmaz et al., 2019). It is necessary for health professionals, especially nurses, to evaluate all women of reproductive age in terms of PMS, to plan educational interventions that will increase their awareness of the issue and enable them to develop appropriate coping strategies, to support the planned educational interventions through written or visual materials, to provide effective and quality counseling services, and to aim to improve women's decreased quality of life (Abay & Kaplan, 2019; Aksoy Derya et al. 2019, Akmalı et al 2020). Women may be advised to do relaxation exercises such as walking, running, swimming, and yoga regularly (at least 30 minutes a day) as they reduce stress by increasing endorphin levels and improve heart rate, lung capacity, and general health (Penedo & Dahn 2005; ACOG 2015; Khajehei 2015). The study aimed to determine the effect of progressive muscle relaxation exercises given to women with premenstrual syndrome on premenstrual syndrome symptoms and violent tendencies.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date August 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. Volunteering to participate in the study, 2. 18-40 years old, 3. At least primary school graduate, 4. Scored 110 and above on the Premenstrual Syndrome Scale, 5. Menstrual cycle length for the last three months is within normal limits (21-35), 6. Women who have not used oral contraceptives for the last three months. Exclusion Criteria: 1. Having a physical or mental illness that would prevent participation in the study, 2. Women who score below 110 points on the Premenstrual Syndrome Scale.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Progressive muscle relaxation exercises
PMI is among the non-pharmacological methods nurses can offer caregivers (Yilmaz et al., 2019). Health professionals, especially nurses, should evaluate all women of reproductive age in terms of PMS, plan educational interventions that will increase their awareness of the issue and enable them to develop appropriate coping strategies, support the planned educational interventions through written or visual materials, provide effective and quality counseling services, and aim to improve women's decreased quality of life (Abay & Kaplan 2019; Aksoy Derya et al. 2019; Akmali et al. 2020). Women can be advised to do relaxation exercises such as walking, running, swimming, and yoga regularly (at least 30 minutes a day) as they reduce stress by increasing endorphin levels and improve heart rate, lung capacity, and general health (Penedo & Dahn, 2005; ACOG, 2015; Khajehei 2015).
Violent tendency Scale
Violent tendency Scale

Locations

Country Name City State
Turkey Siirt Education Research Hospital Si?i?rt Centrum

Sponsors (1)

Lead Sponsor Collaborator
Siirt University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Premenstrual Syndrome Scale The premenstrual Syndrome Scale (PMSS) was developed by Basaran GENÇDOGAN in 2006. The scale consists of 44 items in a 5-point Likert type (never, very rarely, sometimes, frequently, continuously). In the scoring of the scale, 1= never, 2= very rarely, 3= sometimes, 4= frequently, 5= continuously. A minimum score of 44 and a maximum score of 220 can be obtained from the scale. The reliability of the PMSQ was determined by test-retest and internal consistency methods. The reliability of the scale is Cronbach's alpha 0,75. (Gençdogan, 2006). Six month
Secondary The Violence Tendency Scale The Violence Tendency Scale (VTS) was developed by Göka, Bayat, and Türkçapar (1995) to determine aggression and violence tendencies and was redesigned in the research on "Violence in the Family and the Social Sphere" (1998) conducted by the Turkish Prime Ministry Family Research Institute without changing its basic structure and content validity was ensured. The scale includes 20 questions graded between 1-4. On the scale, 1-20 points indicate (a very low tendency to violence), 21-40 points (a low tendency to violence), 41-60 points (a high tendency to violence), and 61-80 points (a very high tendency to violence) (29). Six month
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