Effect of Web-Based Life Style Training and Relaxation Training in Women With Premenstrual Syndrome

NCT06705660 | Completed DMC

• 1 other identifier: PMSWWEB
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effectiveness of web-based lifestyle education and progressive relaxation training provided to women with PMS. During menstruation, an important indicator of reproductive health, women encounter various problems. One of these problems is premenstrual syndrome (PMS). PMS is characterized by its occurrence in 30-40% of women of reproductive age, beginning in the late luteal phase of their menstrual cycle, and presenting with a series of physical, psychological, emotional, behavioral, and social symptoms that end with menstruation. Common symptoms of PMS include changes in appetite, irritability, depression, anxiety, difficulty concentrating, headaches, weight gain, constipation, fatigue, abdominal and lower back pain, breast swelling and tenderness, and mood swings. These symptoms negatively affect the quality of life and participation in social and family activities of women with PMS. Moreover, it leads to reduced productivity in the workforce, lower quality of work life, economic losses, and increased accident potential. Additionally, it has been observed to negatively impact young women's self-esteem, school attendance if they are students, academic success, and willingness to engage in hobbies, thereby affecting their participation in meaningful and purposeful activities-referred to as occupations. Managing lifestyle changes and controlling symptoms in PMS is only possible through behavior change. Recent studies have focused on web-based lifestyle interventions and progressive relaxation training (PRT) to promote behavior change in PMS. The accessibility, ease of use, cost/time efficiency, centralization of user health data, and the ability to update remotely make web-based applications a preferred option in health interventions. In this study, women with PMS will be divided into three groups. The first group will receive web-based lifestyle interventions, the second group will receive web-based PRT, and the third group will serve as a control group without any education. Web-based lifestyle interventions and PRT will be provided by tracking the menstrual cycles of the women. Both interventions will be delivered over the course of two menstrual cycles. A follow-up assessment will be conducted one month after the completion of the trainings (4 weeks later, during the next cycle). Assessments will be planned for both before the intervention (baseline assessment) and after the intervention (8 weeks later). The women's sociodemographic and clinical characteristics related to menstruation will be assessed with the Sociodemographic and Clinical Information Form, their type and severity of premenstrual symptoms with the Premenstrual Syndrome Scale, their anxiety and stress levels with the Hospital Anxiety and Stress Scale, their quality of life with the Nottingham Health Profile, their occupational performance and participation with the Canadian Occupational Performance Measure, and their occupational satisfaction with the Occupational Balance Questionnaire.

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Syndrome; Lifestyle; Relaxation; Women

Outcome Measures

Primary Outcomes (1)

• The Premenstrual Syndrome Scale (PMSS)

  The Premenstrual Syndrome Scale (PMSS) is a 44-item, five-point Likert-type scale (ranging from 'Never' to 'Always') developed to determine the type and severity of PMS symptoms. As stated in the instructions at the beginning of the scale, after reading each item, participants mark their response based on how often they experience that symptom 'within the week before menstruation.' The scoring of the scale assigns points as follows: 'Never' = 1 point, 'Rarely' = 2 points, 'Sometimes' = 3 points, 'Often' = 4 points, and 'Always' = 5 points. The lowest possible score on the scale is 44, and the highest possible score is 220. Based on the scores obtained from the scale, PMS severity can be categorized. A total score of 88 or above indicates severe PMS symptoms, while a score below 88 indicates mild PMS symptoms (Gençdoğan, 2006). In the development study of the scale, Gençdoğan (2006) reported a Cronbach's alpha value of 0.75.

  From enrollment to the end of treatment at 8 weeks

Study Arms (3)

WEB-based lifestyle interventions

ACTIVE COMPARATOR

The web-based lifestyle interventions will be administered to women by monitoring their menstrual cycles for 8 weeks, with sessions held twice a week for 30-45 minutes each (totaling 16 sessions). Measurements will be taken both before the intervention and after its completion. An additional measurement will be conducted during the following menstrual cycle, 4 weeks later, to ensure follow-up.In this study, telehealth and counseling services will be provided. Through telehealth and counseling, women will have the opportunity to communicate online with healthcare professionals and receive guidance on health goals, nutrition, exercise, and stress management

Other: The WEB-based lifestyle interventions

Control Group

NO INTERVENTION

The third group will serve as the control group and will not receive any training.

The WEB-based progressive relaxation training

ACTIVE COMPARATOR

WEB-based progressive relaxation training will be given for 8 weeks, 2 days a week for 30-45 minutes (16 sessions), following the menstrual cycles of women. Measurements will be taken before and after (at the end of) the intervention. Measurements will be taken 4 weeks after the next menstrual cycle to ensure follow-up. Progressive relaxation training is an easy-to-learn, non-invasive and side-effect free method. PGE beginners will be trained for at least 30 minutes and practitioners who have learned the basics of the method will be trained to introduce PGE for 15 minutes. Prior to the PGE, individuals will be informed that they should not come overly hungry or overly full (eating should be finished 2 hours before), wear loose and comfortable clothes, avoid clothes that tightly wrap the abdomen (pants, dresses, belts), remove contact lenses, glasses, jewelry and tight shoes. PGE will be administered in a quiet, comfortable and dimly lit place. Women will perform PCI in the supine posi

Other: WEB-based progressive relaxation training

Interventions

WEB-based progressive relaxation training OTHER

WEB-based progressive relaxation training will be given for 8 weeks, 2 days a week for 30-45 minutes (16 sessions), following the menstrual cycles of women. Measurements will be taken before and after (at the end of) the intervention. Measurements will be taken 4 weeks after the next menstrual cycle to ensure follow-up. Progressive relaxation training is an easy-to-learn, non-invasive and side-effect free method. PGE beginners will be trained for at least 30 minutes and practitioners who have learned the basics of the method will be trained to introduce PGE for 15 minutes. Prior to the PGE, individuals will be informed that they should not come overly hungry or overly full (eating should be finished 2 hours before), wear loose and comfortable clothes, avoid clothes that tightly wrap the abdomen (pants, dresses, belts), remove contact lenses, glasses, jewelry and tight shoes. PGE will be administered in a quiet, comfortable and dimly lit place. Women will perform PCI in the supine posit

The WEB-based progressive relaxation training

The WEB-based lifestyle interventions OTHER

The WEB-based lifestyle interventions will be administered to women by monitoring their menstrual cycles for 8 weeks, with sessions held twice a week for 30-45 minutes each (totaling 16 sessions). Measurements will be taken both before the intervention and after its completion. An additional measurement will be conducted during the following menstrual cycle, 4 weeks later, to ensure follow-up.In this study, telehealth and counseling services will be provided. Through telehealth and counseling, women will have the opportunity to communicate online with healthcare professionals and receive guidance on health goals, nutrition, exercise, and stress management

WEB-based lifestyle interventions

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: The population of the study consists of women, while the sample will be comprised of women aged 18-35 who have Premenstrual Syndrome (PMS). The study group will be formed from women who agree to participate in the study."
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-35 years Menstrual cycle length within normal limits (21-35 days) Presence of premenstrual symptoms Willingness to participate in the study

You may not qualify if:

• Receiving medical or rehabilitative treatment for PMS within the last 6 months
• Suspected pregnancy or history of childbirth
• Use of an intrauterine device
• History of surgery involving the abdominal, pelvic region, and/or spine within the last year
• Use of surgical contraceptives or antidepressants within the last 6 months
• Presence of a diagnosed severe spinal deformity such as scoliosis or any pathology involving the spine (e.g., disc herniation, spondylolisthesis)
• Presence of neurological (headache or migraine), rheumatological, or mental health conditions
• Existence of a cardiopulmonary disease (e.g., Chronic Obstructive Pulmonary Disease, chronic heart failure)
• Body Mass Index (BMI) ≥ 30 kg/m²
• Undergoing treatment for insomnia
• Presence of a dermatological condition (e.g., allergies, psoriasis)
• Difficulty in communicating in Turkish

Sponsors & Collaborators

• Aysenur KARAKUS: lead

Study Sites (1)

Cankırı Karatekin University

Çankırı, Çankırı, 18100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician blinding method will be applied to perform statistical analyses objectively. In this way, the statistician will not know which participant belongs to which group, thereby increasing the objectivity and reliability of the analysis results
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Within the scope of the study, women with Premenstrual Syndrome (PMS) will be divided into three groups. The first group will receive web-based lifestyle interventions, while the second group will be given web-based progressive relaxation training. The third group will serve as the control group and will not receive any training. Assessments will be planned at two stages: before the intervention (baseline assessments) and after the intervention (8 weeks later). The web-based lifestyle interventions and progressive relaxation training will be provided by monitoring the participants' menstrual cycles, ensuring that the training is administered over two menstrual cycles. Evaluations will be conducted both before and after the training periods, and an additional follow-up assessment will be performed one month (4 weeks later-the next cycle) after the completion of the training, to monitor the effects. This approach aims to observe the long-term outcomes of the training.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: November 26, 2024
• Study Start: May 5, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)