The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life
Primary Purpose
Premenstrual Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hydrogenated water consumption
Drinking water consumption
Sponsored by
About this trial
This is an interventional supportive care trial for Premenstrual Syndrome
Eligibility 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.
Sites / Locations
- Ankara University Faculty of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05556252
Brief Title
The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Menekşe Nazlı AKER
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Hydrogenated water consumption
Intervention Description
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
Intervention Name(s)
Drinking water consumption
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in premenstrual symptoms assessed by The Premenstrual Syndrome Scale
Description
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.
Time Frame
immediately before the intervention, immediately after the intervention, and 1 month after the intervention
Title
Change in quality of life assessed by World Health Organization Quality of Life
Description
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.
Time Frame
immediately before the intervention, immediately after the intervention, and 1 month after the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Ankara University Faculty of Nursing
City
Altindağ
State/Province
Ankara
ZIP/Postal Code
06570
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life
We'll reach out to this number within 24 hrs