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

NCT ID: NCT05556252

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-04-28

Brief Summary

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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.

Detailed Description

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Conditions

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Premenstrual Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

Hydrogenated water consumption

Intervention Type 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.

Control Group

Group Type PLACEBO_COMPARATOR

Drinking water consumption

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Menekşe Nazlı AKER

OTHER

Sponsor Role lead

Responsible Party

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Menekşe Nazlı AKER

Assist. Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ankara University Faculty of Nursing

Altindağ, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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0720

Identifier Type: -

Identifier Source: org_study_id

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