The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effect of hydrogenated water on premenstrual symptoms and quality of life in students with premenstrual syndrome. Research Hypotheses H1 1 Hydrogenated water consumption reduces premenstrual symptoms in students with premenstrual syndrome. H1 2 Hydrogenated water consumption increases the quality of life in students with premenstrual syndrome. The research will consist of intervention and control groups. Individuals consuming hydrogen-rich water will be included in the intervention group, whereas individuals consuming normal water will be in the control group. The block randomization method will be used to randomly assign participants who meet the research criteria to the groups. Participants will be provided with hydrogenated water for three cycles.

Official Title
-----------------
The Effect of Hydrogen-rich Water Consumption on Premenstrual Symptoms and Quality of Life in Students With Premenstrual Syndrome: A Randomized Controlled Study

Conditions
-----------------
Premenstrual Syndrome

Intervention / Treatment
-----------------
* Other: Hydrogenated water consumption
* Other: Drinking water consumption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The length of the menstrual cycle is within normal limits (21-35), Getting a score of 132 or more from the Premenstrual Syndrome Scale, Not receiving medical treatment for PMS, Not having any psychiatric diagnosis. Exclusion Criteria: • Irregular menstruation in the last three cycles Having received a psychiatric diagnosis, Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.) Using contraceptive medication. Individuals' refusal to participate in the study, Participants' non-compliance with the research plan, Participants start receiving PMS treatment during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Other: Hydrogenated water consumption<br>* Participants will start consuming hydrogenated water on the 16th day of the menstrual cycle and will continue to apply it until the 2nd day of the next cycle. Within the scope of the study, they will be asked to drink of 300-400 ml hydrogenated water each morning before breakfast; 300-400 ml an hour before lunch; 300-400 ml two hours after lunch; 300-400 ml an hour before dinner; 300-400 ml half an hour before going to bed. Participants will be asked to consume a minimum of 1500 ml (1.5 L) and a maximum of 2000 ml (2.0 L) hydrogenated water in total. In this way, participants will be provided with hydrogenated water for three cycles.<br>|
| Placebo Comparator: Control Group<br> | Other: Drinking water consumption<br>* Participants will start consuming drinking water on the 16th day of the menstrual cycle and will continue to apply it until the 2nd day of the next cycle. Within the scope of the study, they will be asked to drink of 300-400 ml drinking water each morning before breakfast; 300-400 ml an hour before lunch; 300-400 ml two hours after lunch; 300-400 ml an hour before dinner; 300-400 ml half an hour before going to bed. Participants will be asked to consume a minimum of 1500 ml (1.5 L) and a maximum of 2000 ml (2.0 L) drinking water in total. In this way, participants will be provided with drinking water for three cycles.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in premenstrual symptoms assessed by The Premenstrual Syndrome Scale | The Premenstrual Syndrome Scale (PMSS) consists of 44 questions. The PMSS is Likert type and its items are scored between 1 and 5 points. Lowest points of 44 and highest points of 220 can be obtained on the PMSS. The scale has a total of 9 subscales: depressive feeling, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, changes in sleeping habits and swelling. A higher score on the scale indicates that the severity of premenstrual syndrome is high. | immediately before the intervention, immediately after the intervention, and 1 month after the intervention | 
| Change in quality of life assessed by World Health Organization Quality of Life | The brief version of the World Health Organization Quality of Life (WHOQOL-BREF) is a sound, cross-culturally valid assessment of health-related quality of life in adults populations. Its assessment shows good to excellent internal consistency, test-retest reliability, discriminant validity, content validity, and construct validity in the healthy population and in different patient groups. Each question is scored from 1 to 5, with scores ranging from 0-100. A higher score means better quality of life. | immediately before the intervention, immediately after the intervention, and 1 month after the intervention |