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

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mindfulness stres reduction programe
Sponsored by
NURDİLAN SENER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premenstrual Syndrome focused on measuring mindfulness, premenstrual syndrome

Eligibility Criteria

17 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • NURDİLAN
  • Kırklareli Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The Effect of mİNDFULNESS Stress Reduction Program on Premenstrual Symptoms

Control group

Arm Description

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.

not routinely do anything to reduce premenstrual symptoms

Outcomes

Primary Outcome Measures

premenstrual syndrome
This scale, which was developed by Gençdoğan et al. (2006) for the evaluation of premenstrual symptom complaints, consists of 44 questions in total. The scale has nine sub-dimensions: depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and swelling. PMSS is performed by evaluating the person retrospectively, taking into account the status of being "within 1 week before menstruation". The lowest score to be obtained from the scale is 44, and the highest score is 220. High scores indicate an increase in the intensity of PMS. In calculating the scale score, 44 points are considered as No PMS, 45-103 points as PMS Mild, 104-163 points as PMS Moderate, and 164-220 points as PMS Severe Level. Cronbach's α reliability coefficient is between 0.75 for the total scores of the scale and between 0.75 and 0.91 for the subscales. Written permission was obtained from Gençdoğan for the use of the scale.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2021
Last Updated
June 7, 2022
Sponsor
NURDİLAN SENER
Collaborators
Kırklareli University
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1. Study Identification

Unique Protocol Identification Number
NCT05191108
Brief Title
Premenstrual Syndrome (PMS) and Mindfulness Stress Reduction Program (MSRP)
Acronym
PMS and MSRP
Official Title
The Effect of Mindfulness Stress Reduction Program on Premenstrual Symptoms: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
NURDİLAN SENER
Collaborators
Kırklareli University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
mindfulness, premenstrual syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomize Controlled clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Effect of mİNDFULNESS Stress Reduction Program on Premenstrual Symptoms
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
not routinely do anything to reduce premenstrual symptoms
Intervention Type
Behavioral
Intervention Name(s)
mindfulness stres reduction programe
Other Intervention Name(s)
mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
premenstrual syndrome
Description
This scale, which was developed by Gençdoğan et al. (2006) for the evaluation of premenstrual symptom complaints, consists of 44 questions in total. The scale has nine sub-dimensions: depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and swelling. PMSS is performed by evaluating the person retrospectively, taking into account the status of being "within 1 week before menstruation". The lowest score to be obtained from the scale is 44, and the highest score is 220. High scores indicate an increase in the intensity of PMS. In calculating the scale score, 44 points are considered as No PMS, 45-103 points as PMS Mild, 104-163 points as PMS Moderate, and 164-220 points as PMS Severe Level. Cronbach's α reliability coefficient is between 0.75 for the total scores of the scale and between 0.75 and 0.91 for the subscales. Written permission was obtained from Gençdoğan for the use of the scale.
Time Frame
UP TO 16 WEEKS

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
PMS IS ONLY SEEN IN WOMEN
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
NURDİLAN
City
Elaziğ
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
23100
Country
Turkey
Facility Name
Kırklareli Üniversitesi
City
Kırklareli
ZIP/Postal Code
39100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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