Dysmenorrhea PrimaryNCT07865000
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
A study testing Hydrogen-rich water consumption and Drinking water consumption in people with Dysmenorrhea Primary, run by Menekşe Nazlı AKER.
Trial summary
The study will include hydrogen-rich water and control groups. Young women with severe primary dysmenorrhea will be recruited from Ankara University. Eligible women will be informed about the study, and written informed consent will be obtained. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Hydrogen-rich water consumption and Drinking water consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2026to 15 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having regular menstrual cycles occurring every 21-35 days, with bleeding lasting 2-7 days,
- Having severe dysmenorrhea according to the WaLIDD score (8-12 points),
- Having primary dysmenorrhea,
- Being older than 18 years.
Who cannot join
- Regular use of analgesics and anti-inflammatory medications,
- Having any gynecological condition (e.g., abnormal uterine bleeding, uterine fibroids, ovarian cysts, or endometriosis),
- Use of hormonal contraceptives and/or an intrauterine device.
About this study
Official title: The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity in Young Women With Severe Primary Dysmenorrhea
The study will include hydrogen-rich water and control groups. Young women with severe primary dysmenorrhea will be recruited from Ankara University. Eligible women will be informed about the study, and written informed consent will be obtained. Participants will be assigned to the study groups using block randomization.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Hydrogen-rich water consumption, Drinking water consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen-rich water consumptionOther
Participants will begin consuming hydrogen-rich water after menstruation ends in the baseline cycle and continue daily for three months. They will be asked to drink 1,500-2,000 mL (1.5-2.0 L) per day. Adherence will be monitored using a daily water intake log.
Drinking water consumptionOther
Participants will begin consuming water after menstruation ends in the baseline cycle and continue daily for three months. They will be asked to drink 1,500-2,000 mL (1.5-2.0 L) per day. Adherence will be monitored using a daily water intake log.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Hydrogen-rich water consumption |
| Control Group | Placebo comparator | Not described Receives: Other: Drinking water consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
WaLIDD Score
The WaLIDD Score was developed by Teherán et al. The scale, which underwent a Turkish validity and reliability study by Fidancı et al. in 2025, is a four-item assessment tool. Each item is scored between 0 and 3 points, yielding a total score range of 0-12. The scale evaluates four dimensions: work affected (the impact of pain on daily functioning), localization of pain (the anatomical distribution of pain), intensity of pain (a subjective assessment based on the Wong-Baker Faces Pain Scale), and duration of pain (the number of painful days during menstruation). A total score of "0" indicates no dysmenorrhea, scores of "1-4" indicate mild dysmenorrhea, scores of "5-7" indicate moderate dysmenorrhea, and scores of "8-12" indicate severe dysmenorrhea.
Measured: Baseline (days 5-7 of the first menstrual cycle) and follow-up (days 5-7 of the third menstrual cycle)
Secondary outcomes (1)
Menstrual Symptom Questionnaire
The Menstrual Symptom Questionnaire was developed by Chesney and Tasto. The scale, which underwent a Turkish validity and reliability study by Güvenç in 2014, consists of twenty-two items rated on a five-point Likert-type format. Participants rate their menstrual symptoms on a scale from 1 to 5, where 1 indicates "never" and 5 indicates "always." The total score of the Menstrual Symptom Questionnaire is obtained as the mean of the sum of all items. In the original version of the scale, there are three subdimensions: negative affect/somatic complaints, menstrual pain, and abdominal pain.
Measured: Baseline (days 5-7 of the first menstrual cycle) and follow-up (days 5-7 of the third menstrual cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menekşe Nazlı AKER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menekşe Nazlı AKER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865000
- Sponsor's protocol ID
- 27.07.2026-14/195
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided