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

Not Applicable

Completed

• Conditions: Premenstrual Syndrome
• Interventions: Other: Drinking water consumption; Other: Hydrogenated water consumption

• Registration Number: NCT05556252
• Lead Sponsor: Menekşe Nazlı AKER

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Study Start: 2022-10-01
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Drinking water consumption	-
Intervention Group	Hydrogenated water consumption	-

Primary Outcome Measures

Name	Time	Method
Change in premenstrual symptoms assessed by The Premenstrual Syndrome Scale	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.
Change in quality of life assessed by World Health Organization Quality of Life	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.

Trial Locations

Locations (1)

Ankara University Faculty of Nursing; 🇹🇷 Altindağ, Ankara, Turkey