Clinical trial NCT06785766: Effects of Yoga on Balance, Cognition, Posture, and Body Awareness in Premenstrual Syndrome (PMS)
Official title: Investigating the Effects of Yoga-Based Exercises on Balance, Cognitive Function, Posture, and Body Awareness in Young Adults With Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Premenstrual Syndrome-PMS
Keywords: Quality of life
Premenstrual Syndrome
Yoga
Pain
Cognitive Function
Body Awareness
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The women included in the study will be randomized and divided into two groups (arms), 30 participants in each group, as intervention and control groups. Both groups will receive information training at the beginning of the study. The exercise program for the intervention group will consist of 60-minute yoga-based exercise sessions, conducted twice a week for 8 weeks. Additionally, both groups will be instructed to perform a 30-minute walk three times a week.The groups will be formed based on participants' availability, and 8-week yoga flows with gradually increasing difficulty will be applied, based on themes set for each week. Participants assigned to the control group will be asked to continue their routine activities and not to start a new exercise program during the study period. After the second evaluations are completed, the participants in the control group will be offered the opportunity to participate in the yoga program.
Primary purpose: TREATMENT

Brief summary: Premenstrual syndrome (PMS) is characterized by a combination of cognitive, somatic, behavioral, and emotional disorders that occur during the late luteal phase of the menstrual cycle, resolve rapidly after menstruation, and can be severe enough to disrupt daily activities. When reviewing the literature, studies examining the effects of yoga-based exercises on premenstrual syndrome appear to be quite limited. Our aim is to raise awareness among professionals working in this field in our country, contributing to the reduction of symptoms and improvement of the quality of life of individuals with premenstrual syndrome.

Detailed description: Menstruation is a process characterized by symptoms accompanied by emotional, physical, and behavioral changes that occur regularly every month from menarche to menopause, covering an average of 30-35 years of a woman's life. Although menstruation, which constitutes a large period of a woman's life, is a natural physiological cycle, the symptoms that accompany the cycle are among the most common women's health problems.Premenstrual Syndrome (PMS) is defined as 'a condition characterized by distressing physical, behavioral, and psychological symptoms that begin 7-10 days before the menstrual cycle and disappear or significantly decrease with the cessation of menstruation, without being attributed to any underlying psychiatric disorder. Depression, angry outbursts, irritability, anxiety, lack of concentration, and decreased sleep quality are among the most common emotional symptoms of PMS, while physical symptoms include breast tenderness, swelling, fatigue, headache, edema in the extremities, and a feeling of pain or aching. In addition to these frequently seen symptoms in the literature, more than 200 symptoms are defined for PMS. Hormonal fluctuations in women with premenstrual symptoms trigger changes in ligament elasticity, negatively affecting postural balance, coordination and proprioception, and leading to a higher risk of injury. This health issue, which affects many women worldwide, is known to disrupt women's social relationships, increase their tendency to make mistakes or have accidents, reduce work and school performance, and lead to higher rates of sleep problems, substance abuse, criminal behavior, and impaired cognitive functions responsible for memory and emotional control. The etiology of PMS is multifactorial and uncertain, and therefore, there is no definitive treatment method. Although different treatment options are preferred, the aim of the treatment is to relieve the symptoms. Studies have demonstrated that PMS symptoms are more severe in inactive women and that women with severe PMS symptoms are more likely to be inactive. Yoga is one of the oldest methods of personal development, which integrates the body, mind, and spirit, facilitating self-awareness. Yoga increases bodily awareness and cognition as it includes many mind-body exercises such as balancing, stretching, strengthening, physical harmony, breathing and meditation techniques. Studies show that yoga has positive psychological and mental effects on individuals and improves their quality of life. Despite many PMS symptoms negatively impacting a woman's participation in work and social life, there is limited research in the existing literature on specific symptoms. Therefore, this study aims to determine the effectiveness of yoga-based exercises on symptoms in individuals with premenstrual syndrome.

Eligibility criteria: Inclusion Criteria:

* Presence of premenstrual symptoms (scoring 132 or above on the Premenstrual Syndrome Scale (PMSS)),
* Aged 18 and above,
* Able to read and write,
* Willing to participate voluntarily in the study and have signed the informed consent form,
* No problems with cooperation and communication,
* Normal menstrual cycle length (21-35 days) in the past 3 months,
* Not having taken any medications or mineral supplements during the last three menstrual cycles.

Exclusion Criteria:

* Amenorrhea
* Being in the menopausal period
* Pregnancy
* Having given birth
* A diagnosis of cancer
* Having previously practiced yoga
* Having exercise intolerance
* Having received hormone replacement therapy
* Having been enrolled in a physiotherapy program in the past 3 months
* Regular exercise within the past 3 months
* Having musculoskeletal, neurological, serious cardiopulmonary, chronic systemic, psychiatric, balance and coordination, or vestibular system disorders that may prevent participation in exercise

Primary outcomes:
measure: Premenstrual Syndrome Scale (PMSS)
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: Body Awareness Questionnaire
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
Secondary outcomes:
measure: Demographic Information Form Section C
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: Y Balance Test
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: PostureScreen Mobile Application
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: N-Back Test
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: Assessment of Grip Strength
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: Stabilizer Pressure Biofeedback Unit
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: Cough Strength
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: Joint Position Sense Test
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
measure: Premenstrual Symptoms Impact Survey (PMSIS)
timeFrame: The scale will be administered at baseline (prior to the start of the 8-week yoga program) and after the completion of the program (week 8).
Other outcomes:
Locations:
city: Si̇i̇rt
country: Turkey
facility: Siirt University
Study officials:
affiliation: İzmir Democracy University
name: Özlem ÇİNAR ÖZDEMİR, Prof. Dr., PhD
role: STUDY_DIRECTOR
References:
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citation: Aoki M, Suzuki M, Suzuki S, Takao H, Okayama H. Cognitive function evaluation in premenstrual syndrome during the follicular and luteal phases using near-infrared spectroscopy. Compr Psychoneuroendocrinol. 2022 Feb 4;10:100117. doi: 10.1016/j.cpnec.2022.100117. eCollection 2022 May.
citation: Friden C, Hirschberg AL, Saartok T, Backstrom T, Leanderson J, Renstrom P. The influence of premenstrual symptoms on postural balance and kinesthesia during the menstrual cycle. Gynecol Endocrinol. 2003 Dec;17(6):433-9. doi: 10.1080/09513590312331290358.
citation: Kroll-Desrosiers AR, Ronnenberg AG, Zagarins SE, Houghton SC, Takashima-Uebelhoer BB, Bertone-Johnson ER. Recreational Physical Activity and Premenstrual Syndrome in Young Adult Women: A Cross-Sectional Study. PLoS One. 2017 Jan 12;12(1):e0169728. doi: 10.1371/journal.pone.0169728. eCollection 2017.