Effect of Motivational Interviewing and Digital Support on Premenstrual Symptoms and Emotion Regulation

NCT07040553 | Completed

• 2 other identifiers: ADU-MD-PMS-2025-01ETU Ethics Committee 2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Premenstrual Syndrome-PMS; Emotion Regulation

Keywords

Premenstrual Syndrome; Emotion Regulation; Motivational Interviewing; WhatsApp Intervention; Digital Health; University Students; Young Women; Randomized Controlled Trial; Women's health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8 weeks post-intervention

Secondary Outcomes (1)

• Change in Emotion Regulation

  Baseline and 8 weeks post-intervention

Study Arms (2)

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).

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.

Interventions

Motivational Interviewing and WhatsApp Support BEHAVIORAL

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.

Also known as: Behavioral PMS Support Program

Motivational Interviewing and WhatsApp Support

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Eligibility for participation is based on biological sex assigned at birth due to the study's focus on menstrual cycle-related symptoms (premenstrual syndrome). Gender identity was not a factor in inclusion or exclusion criteria.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead
• Erzurum Technical University: collaborator

Study Sites (1)

Erzurum Technical University

Erzurum, Erzurum, 25050, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38133631 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome; Emotional Regulation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ayça Balmumcu, Assistant Professor

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

• Nilüfer Yıldırım, Assistant Professor

  Erzurum Technical University

  STUDY DIRECTOR

• Semra Elmas, Assistant Professor

  European University of Lefke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome data were collected by an independent researcher blinded to group allocation to minimize assessment bias
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: April 14, 2025
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

TU (1)