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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-14

Study Completion Date

2025-06-05

Brief Summary

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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.

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Detailed Description

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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

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Premenstrual Syndrome-PMS Emotion Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Outcome data were collected by an independent researcher blinded to group allocation to minimize assessment bias

Study Groups

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Motivational Interviewing and WhatsApp Support

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).

Group Type EXPERIMENTAL

Motivational Interviewing and WhatsApp Support

Intervention Type 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivational Interviewing and WhatsApp Support

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral PMS Support Program

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes