The Effect of Hydrogen-rich Water Consumption on Premenstrual Symptoms and Quality of Life in Students With Premenstrual Syndrome: A Randomized Controlled Study
Hydrogenated water consumption
+ Drinking water consumption
Menstruation Disturbances+1
+ Pathologic Processes
+ Premenstrual Syndrome
Supportive Care Study
Summary
Study start date: October 1, 2022
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.72 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Ankara University Faculty of Nursing
Altindağ, Turkey (Türkiye)Open Ankara University Faculty of Nursing in Google Maps