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

Premenstrual Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05556252
• Other study ID #: 0720
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: June 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Hydrogenated water consumption
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.
• Drinking water consumption
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.

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Nursing	Altindag	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Menekse Nazli AKER

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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