Premenstrual Syndrome-PMSMIND-PMSNCT07040553
Effect of Motivational Interviewing and Digital Support on Premenstrual Symptoms and Emotion Regulation
A study testing Motivational Interviewing and WhatsApp Support in people with Premenstrual Syndrome-PMS and Emotion Regulation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of an 8-week support program that combines face-to-face motivational interviewing with weekly WhatsApp messages in reducing premenstrual syndrome (PMS) symptoms and improving emotion regulation among university students. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome-PMS, Emotion Regulation
- What is being tested?
- Motivational Interviewing and WhatsApp Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2025to 5 Jun 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female university students
- Own and actively use a smartphone with WhatsApp installed
- Have had a regular menstrual cycle (21-35 days) for the past 6 months
- Diagnosed with moderate or severe PMS based on the Premenstrual Syndrome Scale (PMSS)
- Willing to provide written informed consent
Who cannot join
- Diagnosed with a chronic gynecological condition (e.g., polycystic ovary syndrome, endometriosis)
- Diagnosed with a psychiatric disorder within the past 6 months (e.g., major depression, bipolar disorder, schizophrenia)
- Currently using oral contraceptives
- Currently using medications that may directly affect PMS symptoms (e.g., SSRIs, progesterone-based drugs)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Technical University
Erzurum, Erzurum, 25050
About this study
Official title: The Effect of an 8-Week Motivational Interviewing and Weekly Digital Messaging Intervention on Premenstrual Symptoms and Emotion Regulation in Female University Students: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of an 8-week support program that combines face-to-face motivational interviewing with weekly WhatsApp messages in reducing premenstrual syndrome (PMS) symptoms and improving emotion regulation among university students.
The study was conducted with 70 female students enrolled in the Nursing Department of Erzurum Technical University in Türkiye. Eligible participants are identified using the Premenstrual Syndrome Scale (PMSS), and those scoring above 110 are considered to have PMS. Students who meet the inclusion criteria and volunteer to participate are randomly assigned to either the intervention group (n=35) or the control group (n=35), using a computer-based randomization tool. Housing locations (e.g., dorm rooms or homes) are considered to prevent cross-contamination between groups.
Read more
All participants complete three forms: a Personal Information Form (to gather data on sociodemographic, menstrual, and lifestyle characteristics), the PMSS (to assess PMS severity), and the Difficulties in Emotion Regulation Scale - Short Form (DERS-16). These are completed before the intervention and again at 8 weeks.
The intervention group receives weekly one-on-one motivational interviews and supportive WhatsApp messages based on the principles of Motivational Interviewing as defined by Miller and Rollnick (2012). No medical treatments or devices are used in this study. Participation is voluntary, and informed written consent is obtained from all students. Ethical approval was granted by the Ethics Committee of Erzurum Technical University.
Read the detailed description
This randomized controlled study aims to evaluate the impact of a intervention program on premenstrual syndrome (PMS) symptoms and emotion regulation among female university students in Türkiye. The program includes motivational interviewing and mobile-based support strategies. Participants are selected from nursing students at Erzurum Technical University, based on a set of inclusion criteria such as age, menstrual cycle regularity, and the presence of PMS symptoms above a defined threshold. Individuals with chronic gynecological conditions or recent psychiatric diagnoses are excluded. The minimum required sample size (n = 68) was calculated using G*Power software based on an effect size of 0.76 from Nam and Cha (2019), with α = 0.05 and power = 0.80. To account for potential dropouts and ensure balanced group allocation, a total of 70 eligible participants were recruited and randomly assigned to either the intervention (n = 35) or control (n = 35) group. Data collection tools include the Premenstrual Syndrome Scale (PMSS), the Difficulties in Emotion Regulation Scale - Short Form (DERS-16), and a demographic information form. Ethical approval was obtained from the Ethics Committee of Erzurum Technical University (Decision No: 05/16 - Date: 27.03.2025). Written informed consent was obtained from all participants. The study does not involve the use of any drugs or medical devices.
- Conditions
- Premenstrual Syndrome-PMS, Emotion Regulation
- Being tested
- Motivational Interviewing and WhatsApp Support
- Keywords
- Premenstrual Syndrome, Emotion Regulation, Motivational Interviewing, WhatsApp Intervention, Digital Health, University Students, Young Women, Randomized Controlled Trial, Women's health
- Medical subject headings
- Premenstrual Syndrome, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing and WhatsApp SupportBehavioural
Also called Behavioral PMS Support Program
This intervention consists of weekly face-to-face motivational interviews and supportive WhatsApp messages, delivered over 8 weeks. It is based on the principles of Motivational Interviewing (Miller \& Rollnick, 2012) and aims to support symptom management and emotion regulation in participants with moderate to severe premenstrual syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing and WhatsApp Support | Experimental | Participants in this arm received an 8-week intervention consisting of weekly face-to-face motivational interviews and supportive WhatsApp messages, based on the principles of Motivational Interviewing by Miller and Rollnick (2012). Receives: Behavioral: Motivational Interviewing and WhatsApp Support |
| Control Group | No intervention | Participants in this arm did not receive any intervention during the study period. They completed the same pre- and post-assessments as the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Premenstrual Syndrome Severity
Premenstrual Syndrome severity will be measured using the Premenstrual Syndrome Scale (PMSS). Total score change from pre-test to 8 weeks post-intervention will be assessed.
Measured: Baseline and 8 weeks post-intervention
Secondary outcomes (1)
Change in Emotion Regulation
Emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale - Short Form (DERS-16). Score changes between pre- and post-intervention will be evaluated.
Measured: Baseline and 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start14 Apr 2025
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
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 Syndrome-PMSStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized into two parallel groups (intervention and control) using a computer-based algorithm. Group allocation considered participants' residential settings (e.g., dormitory rooms or homes) to minimize intergroup contamination.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Collaborators
- Erzurum Technical University
- Responsible party
- Principal investigator, Ayca Balmumcu, Aydin Adnan Menderes University
- Investigators
- Ayça Balmumcu, Assistant Professor, Principal investigator, Aydin Adnan Menderes UniversityNilüfer Yıldırım, Assistant Professor, Study director, Erzurum Technical UniversitySemra Elmas, Assistant Professor, Study director, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040553
- Sponsor's protocol ID
- ADU-MD-PMS-2025-01
- Other IDs
- ETU Ethics Committee 2025
- Acronym
- MIND-PMS
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of individual participant data (IPD) has not yet been determined. Data sharing may be considered following publication of the study results, depending on journal requirements, ethical approvals, and participant confidentiality protections.
Publications
Balmumcu A, Ozturk N. The effect of pilates and a WhatsApp-based health intervention program on symptoms of premenstrual syndrome (PMS): A randomized controlled study. Health Care Women Int. 2024;45(8):929-945. doi: 10.1080/07399332.2023.2294819. Epub 2023 Dec 22.
PubMed 38133631
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an 8-Week Motivational Interviewing and Weekly Digital Messaging Intervention on Premenstrual Symptoms and Emotion Regulation in Female University Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07040553
- Acronym / sponsor ID
- MIND-PMS / ADU-MD-PMS-2025-01
- Conditions
- Premenstrual Syndrome-PMS, Emotion Regulation
- Keywords
- Premenstrual Syndrome, Emotion Regulation, Motivational Interviewing, WhatsApp Intervention, Digital Health, University Students, Young Women, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Collaborators
- Erzurum Technical University
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 27 Jun 2025 (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 aims to evaluate the effectiveness of an 8-week support program that combines face-to-face motivational interviewing with weekly WhatsApp messages in reducing premenstrual syndrome (PMS) symptoms and improving emotion regulation among university students.
The study was conducted with 70 female students enrolled in the Nursing Department of Erzurum Technical University in Türkiye. Eligible participants are identified using the Premenstrual Syndrome Scale (PMSS), and those scoring above 110 are considered to have PMS. Students who meet the inclusion criteria and volunteer to participate are randomly assigned to either the intervention group (n=35) or the control group (n=35), using a computer-based randomization tool. Housing locations (e.g., dorm rooms or homes) are considered to prevent cross-contamination between groups.
All participants complete three forms: a Personal Information Form (to gather data on sociodemographic, menstrual, and lifestyle characteristics), the PMSS (to assess PMS severity), and the Difficulties in Emotion Regulation Scale - Short Form (DERS-16). These are completed before the intervention and again at 8 weeks.
The intervention group receives weekly one-on-one motivational interviews and supportive WhatsApp messages based on the principles of Motivational Interviewing as defined by Miller and Rollnick (2012). No medical treatments or devices are used in this study. Participation is voluntary, and informed written consent is obtained from all students. Ethical approval was granted by the Ethics Committee of Erzurum Technical University.
Detailed description
This randomized controlled study aims to evaluate the impact of a intervention program on premenstrual syndrome (PMS) symptoms and emotion regulation among female university students in Türkiye. The program includes motivational interviewing and mobile-based support strategies. Participants are selected from nursing students at Erzurum Technical University, based on a set of inclusion criteria such as age, menstrual cycle regularity, and the presence of PMS symptoms above a defined threshold. Individuals with chronic gynecological conditions or recent psychiatric diagnoses are excluded. The minimum required sample size (n = 68) was calculated using G*Power software based on an effect size of 0.76 from Nam and Cha (2019), with α = 0.05 and power = 0.80. To account for potential dropouts and ensure balanced group allocation, a total of 70 eligible participants were recruited and randomly assigned to either the intervention (n = 35) or control (n = 35) group. Data collection tools include the Premenstrual Syndrome Scale (PMSS), the Difficulties in Emotion Regulation Scale - Short Form (DERS-16), and a demographic information form. Ethical approval was obtained from the Ethics Committee of Erzurum Technical University (Decision No: 05/16 - Date: 27.03.2025). Written informed consent was obtained from all participants. The study does not involve the use of any drugs or medical devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized into two parallel groups (intervention and control) using a computer-based algorithm. Group allocation considered participants' residential settings (e.g., dormitory rooms or homes) to minimize intergroup contamination.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing and WhatsApp Support | Experimental | Behavioral: Motivational Interviewing and WhatsApp SupportParticipants in this arm received an 8-week intervention consisting of weekly face-to-face motivational interviews and supportive WhatsApp messages, based on the principles of Motivational Interviewing by Miller and Rollnick (2012). |
| Control Group | No intervention | –Participants in this arm did not receive any intervention during the study period. They completed the same pre- and post-assessments as the experimental group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female university students
- Own and actively use a smartphone with WhatsApp installed
- Have had a regular menstrual cycle (21-35 days) for the past 6 months
- Diagnosed with moderate or severe PMS based on the Premenstrual Syndrome Scale (PMSS)
- Willing to provide written informed consent
Key exclusion criteria (4 listed)
- Diagnosed with a chronic gynecological condition (e.g., polycystic ovary syndrome, endometriosis)
- Diagnosed with a psychiatric disorder within the past 6 months (e.g., major depression, bipolar disorder, schizophrenia)
- Currently using oral contraceptives
- Currently using medications that may directly affect PMS symptoms (e.g., SSRIs, progesterone-based drugs)
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 |
|---|---|---|
| Motivational Interviewing and WhatsApp SupportAlso: Behavioral PMS Support ProgramThis intervention consists of weekly face-to-face motivational interviews and supportive WhatsApp messages, delivered over 8 weeks. It is based on the principles of Motivational Interviewing (Miller \& Rollnick, 2012) and aims to support symptom management and emotion regulation in participants with moderate to severe premenstrual syndrome. | Behavioural | Motivational Interviewing and WhatsApp Support |
Primary outcome
Change in Premenstrual Syndrome Severity
Time frame: Baseline and 8 weeks post-intervention
Premenstrual Syndrome severity will be measured using the Premenstrual Syndrome Scale (PMSS). Total score change from pre-test to 8 weeks post-intervention will be assessed.
1 secondary outcome
Change in Emotion Regulation
Time frame: Baseline and 8 weeks post-intervention
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 27 Jun 2025.
- Background: PubMed 38133631Balmumcu A, Ozturk N. The effect of pilates and a WhatsApp-based health intervention program on symptoms of premenstrual syndrome (PMS): A randomized controlled study. Health Care Women Int. 2024;45(8):929-945. doi: 10.1080/07399332.2023.2294819. Epub 2023 Dec 22.
- Individual participant dataSharing planned: Undecided. Sharing of individual participant data (IPD) has not yet been determined. Data sharing may be considered following publication of the study results, depending on journal requirements, ethical approvals, and participant confidentiality protections.
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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.
Ayça Balmumcu, Assistant Professor principal investigator
Aydin Adnan Menderes University
Nilüfer Yıldırım, Assistant Professor study director
Erzurum Technical University
Semra Elmas, Assistant Professor study director
European University of Lefke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and WhatsApp Support in people with Premenstrual Syndrome-PMS and Emotion Regulation, run by Aydin Adnan Menderes University 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 5 inclusion and 4 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 27 Jun 2025. 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?
Change in Premenstrual Syndrome Severity (time frame: Baseline and 8 weeks post-intervention). 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 NCT07040553, 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 27 Jun 2025.