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

NCT05556252 | Completed

• 1 other identifier: 0720
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Other: Hydrogenated water consumption

Control Group

PLACEBO COMPARATOR

Other: Drinking water consumption

Interventions

Hydrogenated water consumption OTHER

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.

Intervention Group

Drinking water consumption OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menekşe Nazlı AKER: lead

Study Sites (1)

Ankara University Faculty of Nursing

Altindağ, Ankara, 06570, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Drinking

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 27, 2022
• Study Start: October 1, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)