Clinical trial NCT05191108: Premenstrual Syndrome (PMS) and Mindfulness Stress Reduction Program (MSRP)
Official title: The Effect of Mindfulness Stress Reduction Program on Premenstrual Symptoms: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: mindfulness
premenstrual syndrome
Lead sponsor: Firat University
Sponsor class: OTHER
Collaborators: name: Kırklareli University
First posted: 2022-01-13
Enrollment: 74
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomize Controlled clinical trial
Primary purpose: PREVENTION

Brief summary: Premenstrual syndrome (PMS) is a disorder characterized by emotional, physical and behavioral symptoms that increase the severity of the menstrual cycle in women of reproductive age during the luteal phase and disappear spontaneously a few days after the onset of menstruation. Nonpharmacological applications are often preferred to reduce premenstrual symptoms. It has been stated that with the meditation practices of mindfulness, individuals experience less anxiety, depression, anger and lower levels of psychological distress, including anxiety. . It is thought that the mindfulness stress reduction program can reduce the symptoms of PMS by regulating the stress level and emotional balance of women.

Detailed description: Premenstrual syndrome (PMS) is a disorder characterized by emotional, physical and behavioral symptoms that increase the severity of the menstrual cycle in women of reproductive age during the luteal phase and disappear spontaneously a few days after the onset of menstruation. It is stated in the literature that more than 40 million women experience PMS symptoms. While PMS significantly affects 20% of women's daily lives, it manifests itself as mild premenstrual symptoms in 90% of women. It is stated that PMS is associated with more than 300 physical, psychological, emotional, behavioral and social symptoms. These symptoms can include changes in appetite, weight gain, abdominal pain, backache, lower back pain, headache, breast swelling and tenderness, nausea, constipation, anxiety, irritability, anger, fatigue, restlessness, mood swings, and crying. Therefore, premenstrual symptoms can negatively affect individuals' participation in courses, school success, social activities and family relationships. Recently, in addition to pharmacological applications, non-pharmacological applications are frequently preferred to reduce premenstrual symptoms (reflexology, acupuncture, acupressure, music, mindfulness).

Mindfulness is defined as directing one's non-judgmental attention to thoughts, feelings, bodily sensations, and interactions. It has been stated that with the meditation practices of mindfulness, individuals experience less anxiety, depression, anger and lower levels of psychological distress, including anxiety. . PMS is an important health problem with complex symptoms. To cope with these symptoms, PMS needs to be addressed in a multidimensional way. It is thought that the mindfulness stress reduction program can reduce the symptoms of PMS by regulating the stress level and emotional balance of women. When the domestic studies were examined, there was no study that evaluated the effect of mindfulness stress reduction program on PMS, while when the foreign literature was examined, it was determined that there were studies conducted in a limited number and with a small sample, in which the effect of mindfulness stress reduction program on PMS was evaluated. This research was planned as a single-blind randomized controlled experimental study to evaluate the effect of mindfulness stress reduction program on the reduction of premenstrual symptoms in coping with premenstrual syndrome.

Eligibility criteria: Inclusion Criteria:

* be between the ages of 18-30
* Having a score of 45 or more on the PMS scale
* Regular menstruation (between 21-35 days)
* Knowing Turkish (being literate)
* Read and approve the voluntary consent form

Exclusion Criteria:

* Having any gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.),
* Having a chronic or physical illness (having serious hearing and vision problems, vestibular disorders that can cause balance loss)
* Having any problem that prevents communication (such as not knowing Turkish, having impairment in hearing, speaking and understanding abilities)
* Receiving a psychiatric treatment (Pharmacotherapy or psychotherapy)
* Do not use pharmacological or non-pharmacological applications to reduce the symptoms of premenstrual symptoms.

Primary outcomes:
measure: premenstrual syndrome
timeFrame: UP TO 16 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Elaziğ
country: Turkey
facility: NURDİLAN
state: Eyalet/Yerleşke
city: Kırklareli
country: Turkey
facility: Kırklareli Üniversitesi
Study officials:
References: