- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05556252
The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life
The Effect of Hydrogen-rich Water Consumption on Premenstrual Symptoms and Quality of Life in Students With Premenstrual Syndrome: A Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: İlknur Gönenç
- Phone Number: +903123191450
- Email: imgonenc@gmail.com
Study Locations
-
-
Ankara
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Altindağ, Ankara, Turkey, 06570
- Ankara University Faculty of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
|
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.
|
Placebo Comparator: Control Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in premenstrual symptoms assessed by The Premenstrual Syndrome Scale
Time Frame: immediately before the intervention, immediately after the intervention, and 1 month after the intervention
|
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
Time Frame: immediately before the intervention, immediately after the intervention, and 1 month after the intervention
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0720
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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