Premenstrual SyndromePMS and MSRPNCT05191108
Premenstrual Syndrome (PMS) and Mindfulness Stress Reduction Program (MSRP)
A study testing mindfulness stres reduction programe in people with Premenstrual Syndrome, run by NURDİLAN SENER at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- mindfulness stres reduction programe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Feb 2022to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
NURDİLAN
Elâzığ, Eyalet/Yerleşke, 23100
Kırklareli Üniversitesi
Kırklareli, 39100
About this study
Official title: The Effect of Mindfulness Stress Reduction Program on Premenstrual Symptoms: A Randomized Controlled Study
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.
Read the 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
- Being tested
- mindfulness stres reduction programe
- Keywords
- mindfulness, premenstrual syndrome
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness stres reduction programeBehavioural
Also called mindfulness
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.
| Study group | Role | What they receive |
|---|---|---|
| The Effect of mİNDFULNESS Stress Reduction Program on Premenstrual Symptoms | Experimental | 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. Receives: Behavioral: mindfulness stres reduction programe |
| Control group | No intervention | not routinely do anything to reduce premenstrual symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: UP TO 16 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start21 Feb 2022
- Primary completion21 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomize Controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- NURDİLAN SENER
- Sponsor type
- University, hospital or other
- Collaborators
- Kırklareli University
- Responsible party
- Sponsor-investigator, NURDİLAN SENER, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191108
- Sponsor's protocol ID
- Firat Universityyy
- Acronym
- PMS and MSRP
- Status last verified
- Jun 2022
- First submitted
- 28 Dec 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37335817
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Stress Reduction Program on Premenstrual Symptoms: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05191108
- Acronym / sponsor ID
- PMS and MSRP / Firat Universityyy
- Conditions
- Premenstrual Syndrome
- Keywords
- mindfulness, premenstrual syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- NURDİLAN SENERUniversity, hospital or other
- Collaborators
- Kırklareli University
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomize Controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| The Effect of mİNDFULNESS Stress Reduction Program on Premenstrual Symptoms | Experimental | Behavioral: mindfulness stres reduction programeIn 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. |
| Control group | No intervention | –not routinely do anything to reduce premenstrual symptoms |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness stres reduction programeAlso: mindfulnessComplaints 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. | Behavioural | The Effect of mİNDFULNESS Stress Reduction Program on Premenstrual Symptoms |
Primary outcome
premenstrual syndrome
Time frame: UP TO 16 WEEKS
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Derived from this study: PubMed 37335817Sener 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness stres reduction programe in people with Premenstrual Syndrome, run by NURDİLAN SENER at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
premenstrual syndrome (time frame: UP TO 16 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.