Premenstrual SyndromeNCT07360197
MBSR for Premenstrual Syndrome and Childbirth Fear
A study testing MBSR Intervention Group in people with Premenstrual Syndrome and Fear of Childbirth, run by Aysel AKBENIZ at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program on premenstrual symptom severity, fear of childbirth, and psychological well-being in women experiencing Premenstrual Syndrome (PMS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premenstrual Syndrome, Fear of Childbirth, Psychological Well-being
- What is being tested?
- MBSR Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Nov 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years or older
- Regular menstrual cycles (21-35 days)
- Premenstrual Syndrome Scale (PMSS) total score ≥110
- Willingness to participate and provide informed consent
Who cannot join
- Presence of any gynecological disorder (e.g., abnormal uterine bleeding, fibroids, ovarian cysts)
- Use of hormonal contraceptives or contraceptive pills
- Failure to attend more than two MBSR sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth and Psychological Well-being in Women Experiencing Premenstrual Syndrome
This randomized controlled trial evaluates the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program on premenstrual symptom severity, fear of childbirth, and psychological well-being in women experiencing Premenstrual Syndrome (PMS). PMS is a prevalent condition characterized by emotional, cognitive, and physical symptoms that significantly impair women's daily functioning, stress tolerance, and quality of life. In addition to its somatic and affective burden, PMS is associated with increased anxiety and emotional dysregulation, which may contribute to elevated fear related to pregnancy and childbirth during the preconception period.
A total of 126 women aged 18 years and older who met the diagnostic threshold for PMS (Premenstrual Syndrome Scale score ≥ 110) were enrolled between June 2023 and November 2025 and randomly assigned in a 1:1 ratio to either an MBSR intervention group or a control group. The intervention group received an eight-session online MBSR program delivered twice weekly, with each session lasting 40 minutes. The program included mindfulness-based practices such as body scan, breath awareness, emotion-focused mindfulness, and cognitive awareness exercises, supported by structured home practice assignments. The control group received no active intervention during the study period.
Read more
Primary and secondary outcomes were assessed using validated self-report instruments at baseline and after completion of the 8-week intervention period. Premenstrual symptom severity was measured using the Premenstrual Syndrome Scale (PMSS), fear of childbirth was evaluated with the Childbirth Fear-Prior to Pregnancy Scale (CF-PPS), and psychological well-being was assessed using the Psychological Well-Being Scale (PWBS).
The primary objective of the study is to determine whether participation in the MBSR program leads to a greater reduction in premenstrual symptom severity compared to a control condition. Secondary objectives include evaluating the effect of MBSR on reducing fear of childbirth and improving psychological well-being. This study aims to provide evidence for the effectiveness of a non-pharmacological, mindfulness-based intervention in supporting women's mental and reproductive health during the premenstrual period.
Read the detailed description
Premenstrual Syndrome (PMS) is a common cyclical condition characterized by a wide range of physical, emotional, and behavioral symptoms that occur during the late luteal phase of the menstrual cycle. These symptoms, which include depressed mood, anxiety, irritability, fatigue, pain, and somatic discomfort, can significantly impair daily functioning, interpersonal relationships, academic and occupational performance, and overall quality of life. Beyond its somatic manifestations, PMS is increasingly recognized as a condition with substantial psychological and emotional consequences. Elevated stress reactivity, emotional dysregulation, and negative cognitive appraisals commonly observed in women with PMS may also contribute to heightened vulnerability to anxiety-related conditions, including fear of pregnancy and childbirth during the preconception period.
Fear of childbirth is a multidimensional construct encompassing cognitive, emotional, and physiological components, including catastrophic thinking, loss of control, bodily hypervigilance, and intolerance of uncertainty. Although most studies focus on fear of childbirth during pregnancy, emerging evidence suggests that such fear can develop long before conception, particularly among women experiencing high levels of anxiety, stress, and mood instability. Given the emotional and neuroendocrine fluctuations associated with PMS, women with severe premenstrual symptoms may be at increased risk for elevated fear related to pregnancy and childbirth. PMS has also been shown to negatively affect psychological well-being by reducing individuals' perceived sense of competence, life satisfaction, and capacity to cope with stress.
Mindfulness-Based Stress Reduction (MBSR) is a structured psychosocial intervention designed to enhance present-moment awareness, emotional regulation, and adaptive coping through mindfulness meditation, body awareness, and cognitive decentering. MBSR has demonstrated beneficial effects on stress, anxiety, depression, and psychological well-being in diverse clinical and non-clinical populations. By fostering nonjudgmental awareness of bodily sensations, emotions, and thoughts, MBSR may reduce the intensity of premenstrual symptoms, weaken maladaptive cognitive responses to discomfort, and improve overall psychological functioning. Furthermore, by promoting acceptance, self-regulation, and resilience, mindfulness-based approaches may reduce fear-related cognitive and emotional reactions associated with childbirth.
This study was designed as a randomized controlled trial to evaluate the effects of an MBSR program on premenstrual symptom severity, fear of childbirth, and psychological well-being in women experiencing PMS. The trial was conducted between June 2023 and November 2025. Eligible participants were women aged 18 years or older with regular menstrual cycles who met the diagnostic threshold for PMS based on a Premenstrual Syndrome Scale score of 110 or higher. Women with gynecological disorders or those using hormonal contraceptives were excluded.
After providing informed consent and completing baseline assessments, participants were randomly assigned in a 1:1 ratio to either the MBSR intervention group or a control group using computer-generated randomization. The intervention group received an eight-session MBSR program delivered online via Zoom. Sessions were conducted twice weekly, each lasting 40 minutes, and were facilitated by a certified mindfulness instructor. The program included structured mindfulness practices such as body scan, breath awareness, raisin exercise, attention to thoughts and emotions, and mindfulness-based coping strategies. Participants were encouraged to engage in regular home practice through assigned exercises. The control group did not receive any active intervention during the study period but completed the same assessment schedule.
Primary and secondary outcome measures were administered at baseline and immediately after completion of the 8-week intervention. Premenstrual symptom severity was assessed using the Premenstrual Syndrome Scale (PMSS), which evaluates emotional, cognitive, and somatic symptoms. Fear of childbirth was measured with the Childbirth Fear-Prior to Pregnancy Scale (CF-PPS), a validated instrument assessing fear related to pregnancy and birth before conception. Psychological well-being was evaluated using the Psychological Well-Being Scale (PWBS), which captures individuals' psychological resources, positive functioning, and overall mental well-being.
The primary objective of the study is to determine whether the MBSR intervention results in a greater reduction in PMS symptom severity compared with a control condition. Secondary objectives include assessing whether MBSR reduces fear of childbirth and enhances psychological well-being. Statistical analyses compare post-intervention outcomes between groups while controlling for baseline scores to estimate the effect of the intervention.
This trial aims to provide evidence for the role of mindfulness-based interventions as safe, feasible, and effective non-pharmacological strategies for improving women's mental health and reproductive well-being during the premenstrual period.
- Being tested
- MBSR Intervention Group
- Keywords
- Mindfulness-Based Stress Reduction, MBSR, Premenstrual Syndrome, Childbirth Fear, Psychological Well-being, Women's Mental Health, Behavioral Intervention, Randomized Controlled Trial
- Medical subject headings
- Premenstrual Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR Intervention GroupBehavioural
A structured 8-session mindfulness-based stress reduction program designed to enhance awareness, emotion regulation, and stress coping. The intervention included guided mindfulness practices such as body scan, breathing exercises, emotional awareness, and cognitive mindfulness strategies delivered online by a certified instructor.
| Study group | Role | What they receive |
|---|---|---|
| MBSR Intervention Group | Experimental | articipants in this arm received an 8-session Mindfulness-Based Stress Reduction (MBSR) program delivered online. Each session lasted 40 minutes and was conducted twice weekly. The program included mindfulness practices such as body scan, breath awareness, emotional awareness, and mindfulness-based coping strategies, along with home practice assignments. Receives: Behavioral: MBSR Intervention Group |
| Control Group | No intervention | Participants in this arm did not receive any active intervention during the study period. They completed baseline and post-intervention assessments only and were provided with an information booklet after completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Severity
Change in total score of the Premenstrual Syndrome Scale (PMSS) from baseline to post-intervention at 8 weeks.
Measured: Baseline to 8 weeks
Secondary outcomes (2)
Fear of Childbirth
Change in score on the Childbirth Fear - Prior to Pregnancy Scale (CF-PPS) from baseline to post-intervention at 8 weeks.
Measured: Baseline to 8 weeks
Psychological Well-being
Change in total score on the Psychological Well-being Scale (PWBS) from baseline to post-intervention at 8 weeks.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jun 2023
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysel AKBENIZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysel AKBENIZ, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360197
- Sponsor's protocol ID
- INONU-CT-4615-MBSR
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth and Psychological Well-being in Women Experiencing Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT07360197
- Acronym / sponsor ID
- INONU-CT-4615-MBSR
- Keywords
- Mindfulness-Based Stress Reduction, MBSR, Premenstrual Syndrome, Childbirth Fear, Psychological Well-being, Women's Mental Health, Behavioral Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Aysel AKBENIZUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 22 Jan 2026 (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.
This randomized controlled trial evaluates the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program on premenstrual symptom severity, fear of childbirth, and psychological well-being in women experiencing Premenstrual Syndrome (PMS). PMS is a prevalent condition characterized by emotional, cognitive, and physical symptoms that significantly impair women's daily functioning, stress tolerance, and quality of life. In addition to its somatic and affective burden, PMS is associated with increased anxiety and emotional dysregulation, which may contribute to elevated fear related to pregnancy and childbirth during the preconception period.
A total of 126 women aged 18 years and older who met the diagnostic threshold for PMS (Premenstrual Syndrome Scale score ≥ 110) were enrolled between June 2023 and November 2025 and randomly assigned in a 1:1 ratio to either an MBSR intervention group or a control group. The intervention group received an eight-session online MBSR program delivered twice weekly, with each session lasting 40 minutes. The program included mindfulness-based practices such as body scan, breath awareness, emotion-focused mindfulness, and cognitive awareness exercises, supported by structured home practice assignments. The control group received no active intervention during the study period.
Primary and secondary outcomes were assessed using validated self-report instruments at baseline and after completion of the 8-week intervention period. Premenstrual symptom severity was measured using the Premenstrual Syndrome Scale (PMSS), fear of childbirth was evaluated with the Childbirth Fear-Prior to Pregnancy Scale (CF-PPS), and psychological well-being was assessed using the Psychological Well-Being Scale (PWBS).
The primary objective of the study is to determine whether participation in the MBSR program leads to a greater reduction in premenstrual symptom severity compared to a control condition. Secondary objectives include evaluating the effect of MBSR on reducing fear of childbirth and improving psychological well-being. This study aims to provide evidence for the effectiveness of a non-pharmacological, mindfulness-based intervention in supporting women's mental and reproductive health during the premenstrual period.
Detailed description
Premenstrual Syndrome (PMS) is a common cyclical condition characterized by a wide range of physical, emotional, and behavioral symptoms that occur during the late luteal phase of the menstrual cycle. These symptoms, which include depressed mood, anxiety, irritability, fatigue, pain, and somatic discomfort, can significantly impair daily functioning, interpersonal relationships, academic and occupational performance, and overall quality of life. Beyond its somatic manifestations, PMS is increasingly recognized as a condition with substantial psychological and emotional consequences. Elevated stress reactivity, emotional dysregulation, and negative cognitive appraisals commonly observed in women with PMS may also contribute to heightened vulnerability to anxiety-related conditions, including fear of pregnancy and childbirth during the preconception period.
Fear of childbirth is a multidimensional construct encompassing cognitive, emotional, and physiological components, including catastrophic thinking, loss of control, bodily hypervigilance, and intolerance of uncertainty. Although most studies focus on fear of childbirth during pregnancy, emerging evidence suggests that such fear can develop long before conception, particularly among women experiencing high levels of anxiety, stress, and mood instability. Given the emotional and neuroendocrine fluctuations associated with PMS, women with severe premenstrual symptoms may be at increased risk for elevated fear related to pregnancy and childbirth. PMS has also been shown to negatively affect psychological well-being by reducing individuals' perceived sense of competence, life satisfaction, and capacity to cope with stress.
Mindfulness-Based Stress Reduction (MBSR) is a structured psychosocial intervention designed to enhance present-moment awareness, emotional regulation, and adaptive coping through mindfulness meditation, body awareness, and cognitive decentering. MBSR has demonstrated beneficial effects on stress, anxiety, depression, and psychological well-being in diverse clinical and non-clinical populations. By fostering nonjudgmental awareness of bodily sensations, emotions, and thoughts, MBSR may reduce the intensity of premenstrual symptoms, weaken maladaptive cognitive responses to discomfort, and improve overall psychological functioning. Furthermore, by promoting acceptance, self-regulation, and resilience, mindfulness-based approaches may reduce fear-related cognitive and emotional reactions associated with childbirth.
This study was designed as a randomized controlled trial to evaluate the effects of an MBSR program on premenstrual symptom severity, fear of childbirth, and psychological well-being in women experiencing PMS. The trial was conducted between June 2023 and November 2025. Eligible participants were women aged 18 years or older with regular menstrual cycles who met the diagnostic threshold for PMS based on a Premenstrual Syndrome Scale score of 110 or higher. Women with gynecological disorders or those using hormonal contraceptives were excluded.
After providing informed consent and completing baseline assessments, participants were randomly assigned in a 1:1 ratio to either the MBSR intervention group or a control group using computer-generated randomization. The intervention group received an eight-session MBSR program delivered online via Zoom. Sessions were conducted twice weekly, each lasting 40 minutes, and were facilitated by a certified mindfulness instructor. The program included structured mindfulness practices such as body scan, breath awareness, raisin exercise, attention to thoughts and emotions, and mindfulness-based coping strategies. Participants were encouraged to engage in regular home practice through assigned exercises. The control group did not receive any active intervention during the study period but completed the same assessment schedule.
Primary and secondary outcome measures were administered at baseline and immediately after completion of the 8-week intervention. Premenstrual symptom severity was assessed using the Premenstrual Syndrome Scale (PMSS), which evaluates emotional, cognitive, and somatic symptoms. Fear of childbirth was measured with the Childbirth Fear-Prior to Pregnancy Scale (CF-PPS), a validated instrument assessing fear related to pregnancy and birth before conception. Psychological well-being was evaluated using the Psychological Well-Being Scale (PWBS), which captures individuals' psychological resources, positive functioning, and overall mental well-being.
The primary objective of the study is to determine whether the MBSR intervention results in a greater reduction in PMS symptom severity compared with a control condition. Secondary objectives include assessing whether MBSR reduces fear of childbirth and enhances psychological well-being. Statistical analyses compare post-intervention outcomes between groups while controlling for baseline scores to estimate the effect of the intervention.
This trial aims to provide evidence for the role of mindfulness-based interventions as safe, feasible, and effective non-pharmacological strategies for improving women's mental health and reproductive well-being during the premenstrual period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR Intervention Group | Experimental | Behavioral: MBSR Intervention Grouparticipants in this arm received an 8-session Mindfulness-Based Stress Reduction (MBSR) program delivered online. Each session lasted 40 minutes and was conducted twice weekly. The program included mindfulness practices such as body scan, breath awareness, emotional awareness, and mindfulness-based coping strategies, along with home practice assignments. |
| Control Group | No intervention | –Participants in this arm did not receive any active intervention during the study period. They completed baseline and post-intervention assessments only and were provided with an information booklet after completion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants aged 18 years or older
- Regular menstrual cycles (21-35 days)
- Premenstrual Syndrome Scale (PMSS) total score ≥110
- Willingness to participate and provide informed consent
Key exclusion criteria (3 listed)
- Presence of any gynecological disorder (e.g., abnormal uterine bleeding, fibroids, ovarian cysts)
- Use of hormonal contraceptives or contraceptive pills
- Failure to attend more than two MBSR sessions
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 |
|---|---|---|
| MBSR Intervention GroupA structured 8-session mindfulness-based stress reduction program designed to enhance awareness, emotion regulation, and stress coping. The intervention included guided mindfulness practices such as body scan, breathing exercises, emotional awareness, and cognitive mindfulness strategies delivered online by a certified instructor. | Behavioural | MBSR Intervention Group |
Primary outcome
Premenstrual Syndrome Severity
Time frame: Baseline to 8 weeks
Change in total score of the Premenstrual Syndrome Scale (PMSS) from baseline to post-intervention at 8 weeks.
2 secondary outcomes
Fear of Childbirth
Time frame: Baseline to 8 weeks
Psychological Well-being
Time frame: Baseline to 8 weeks
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 26 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR Intervention Group in people with Premenstrual Syndrome and Fear of Childbirth, run by Aysel AKBENIZ at 1 site 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 4 inclusion and 3 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Severity (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.