Premenstrual Syndrome (PMS) and Mindfulness Stress Reduction Program (MSRP)

NCT ID: NCT05191108

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2022-04-30

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.

Conditions

Premenstrual Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

The Effect of mİNDFULNESS Stress Reduction Program on Premenstrual Symptoms

In order to prevent bias in the study groups, the Introductory Information Form and PMSS scale will be applied via online Google forms. Participants who meet the criteria will be randomly assigned to the mindfulness stress reduction group (Group 1) and control group (Group 2) in the number determined by power analysis and a simple random number generator program (www.random.org). These experimental and control groups will be recorded by the researchers as a list. Participants participating in the study will be informed about the mindfulness stress reduction application, but they will not be informed about what the mindfulness stress reduction application does (single-blind method). These participants will be asked to sign the consent form by expressing that they can withdraw from the study at any time.

Group Type: EXPERIMENTAL

mindfulness stres reduction programe

Intervention Type: BEHAVIORAL

Complaints about PMS and sharing information about these complaints, Practice of breathing focused meditation, mplementation of mindful eating exercises,Raising awareness in daily activities,Teaching the body scanning exercise and repeating this practice during the week with the audio recordings given.Ensuring environmental awareness Ensuring that you live by being aware of the moments experienced during the week, 20 minutes of sitting breathing focused sitting meditation Coping with stress Sharing the experiences of the previous week Implementation of mindful vision practices Explaining the relationship between stress and experienced events.Eating exercises Mindful breathing Ensuring environmental awareness Explaining the importance of thinking about the relationship between stress and their reactions and accepting them without judgment, and sharing the experiences at the end of the day of silence.

Control group

not routinely do anything to reduce premenstrual symptoms

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mindfulness stres reduction programe

Complaints about PMS and sharing information about these complaints, Practice of breathing focused meditation, mplementation of mindful eating exercises,Raising awareness in daily activities,Teaching the body scanning exercise and repeating this practice during the week with the audio recordings given.Ensuring environmental awareness Ensuring that you live by being aware of the moments experienced during the week, 20 minutes of sitting breathing focused sitting meditation Coping with stress Sharing the experiences of the previous week Implementation of mindful vision practices Explaining the relationship between stress and experienced events.Eating exercises Mindful breathing Ensuring environmental awareness Explaining the importance of thinking about the relationship between stress and their reactions and accepting them without judgment, and sharing the experiences at the end of the day of silence.

Intervention Type: BEHAVIORAL

Other Intervention Names

mindfulness

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kırklareli University

OTHER

Sponsor Role: collaborator

NURDİLAN SENER

OTHER

Sponsor Role: lead

Responsible Party

NURDİLAN SENER

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

NURDİLAN

Elâzığ, Eyalet/Yerleşke, Turkey (Türkiye)

Kırklareli Üniversitesi

Kırklareli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Sener Cetin N, Solt Kirca A. The Effect of a Mindfulness-Based Stress Reduction Program on Premenstrual Symptoms: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Sep-Oct;68(5):604-610. doi: 10.1111/jmwh.13530. Epub 2023 Jun 19.

Reference Type: DERIVED

PMID: 37335817 (View on PubMed)

Other Identifiers

Firat Universityyy

Identifier Type: -

Identifier Source: org_study_id