Dysmenorrhea PrimaryNCT07391930
High-Intensity Interval Training and Menstrual Health Experience in Primary Dysmenorrhea.
A study testing Supervised Online HIIT Program and Menstrual Health Workshop in people with Dysmenorrhea Primary and Menstrual Pain, run by University of Alcala at 1 site in Spain.
Trial summary
The goal of this study is to evaluate whether a 12-week online supervised high-intensity interval training program can reduce menstrual pain and improve quality of life in women with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Dysmenorrhea Primary, Menstrual Pain, Pelvic Pain
- What is being tested?
- Supervised Online HIIT Program and Menstrual Health Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- nulliparous
- primary dysmenorrhea
- body mass index between 18 and 30
- menstrual pain >5 according to the Numeric Pain Scale
- exercise >45 minutes/week
- understand Spanish and can freely read and sign the informed consent form
Who cannot join
- amenorrhea or cycles >35 days
- secondary dysmenorrhea
- pelvic or abdominal surgical intervention
- use of hormonal drugs
- diagnosed with fibromyalgia, muscoloskeletal injuries or medical comorbidities that prevent them from performing intense exercise
- receiving physiotherapy for pelvic floor disorders
- intense exercise >75 minutes/week
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Alcalá, Facultad de Enfermeria y Fisioterapia
Alcalá de Henares, Madrid, 28801
Esther M Pindado Perez, PhD Student, +34 689714447, esther.pindado@edu.uah.es
About this study
Official title: Efficacy of a High-Intensity Interval Training Program and Analysis of Menstrual Health Experience in Women With Primary Dysmenorrhea: A Mixed-Methods Randomized Controlled Trial.
The goal of this study is to evaluate whether a 12-week online supervised high-intensity interval training program can reduce menstrual pain and improve quality of life in women with primary dysmenorrhea. Participants will be divided into two groups: one receiving an educational workshop and the HIIT program, and a control group receiving only the workshop. Additionally, the study seeks to understand the personal experience of these women through weekly health diaries, exploring how the intervention affects their relationship with their bodies and their menstruation. The ultimate goal is to offer new, non-pharmacological evidence-based tools for managing menstrual pain.
Read the detailed description
This research follows a convergent mixed-methods design integrating a randomized controlled trial with a descriptive qualitative study.
Fifty women (aged 18-40) with primary dysmenorrhea will be randomized into two arms:
Experimental Group: 12 weeks of online supervised HIIT (2 sessions/week) plus a menstrual health educational workshop.
Control Group: Menstrual health educational workshop only. Clinical variables (pain intensity via NRS, quality of life via SF-12, and pain characteristics via McGill Questionnaire) will be collected at baseline, 3 months (post-intervention), and 6 months (follow-up).
Simultaneously, all participants will complete a weekly semi-structured digital diary for 12 weeks. These diaries are designed to capture the "thick description" of their menstrual health experience, focusing on the evolution of their relationship with their body and menstruation, perceptions of self-management and empowerment and barriers and facilitators for adherence to the exercise program (in the experimental group).
Following the convergent design, quantitative statistical results will be integrated with the thematic analysis of the diaries. This merging of data will provide a holistic understanding of how high-intensity exercise influences not only physical symptoms but also the biopsychosocial perception of menstrual health in young women.
- Conditions
- Dysmenorrhea Primary, Menstrual Pain, Pelvic Pain
- Being tested
- Supervised Online HIIT Program, Menstrual Health Workshop
- Keywords
- High- Intensity Interval Training, Quality of Life, Menstrual Health, Therapeutic Exercise
- Medical subject headings
- Dysmenorrhea, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Online HIIT ProgramBehavioural
The intervention consists of a total of 24 exercise sessions delivered over 12 weeks (frequency: 2 sessions per week). Each session is conducted online and supervised in real-time by a physical therapist. The 24 sessions follow a structured progression of high-intensity intervals, separated by active recovery periods.
Menstrual Health WorkshopBehavioural
A 2-hour online educational session covering menstrual cycle physiology, pain neurophysiology, and self-care strategies. This intervention aims to improve menstrual health literacy and provide tools for pain self-management
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education Workshop | Experimental | Participants in this arm will receive a 2-hour online menstrual health education workshop and will perform 2 sessions per week of supervised online High-Intensity Interval Training (HIIT) for 12 weeks. They will also complete weekly qualitative diaries. Receives: Behavioral: Supervised Online HIIT Program; Behavioral: Menstrual Health Workshop |
| Menstrual Health Education Workshop | Active comparator | Participants in this arm will receive the same 2-hour online menstrual health education workshop and will complete the same weekly qualitative diaries, but will not perform the HIIT program during the 12-week study period. Receives: Behavioral: Menstrual Health Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Menstrual Pain Intensity
Measured using the Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will report their peak pain intensity during their menstrual period.
Measured: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
Secondary outcomes (5)
Health-Related Quality of Life
Assessed using the Short Form-12 (SF-12) Health Survey, which measures physical and mental health components. Higher scores indicate better quality of life.
Measured: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
Participant Menstrual Health Experience and Self-Management.
Qualitative assessment through the thematic analysis of weekly semi-structured digital diaries. This measure explores the evolution of the participants' relationship with their bodies, the practical application of self-care strategies, and the subjective perception of the intervention's impact. Data will be analyzed using a phenomenological approach to identify emerging themes.
Measured: Weekly during the 12-week intervention period
Quality of Sleep
Assessed using the Pittsburgh Sleep Quality Index (PSQI). It measures seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, where higher scores indicate poorer sleep quality.
Measured: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
Levels of Depression, Anxiety, and Stress
Measured using the Depression, Anxiety, and Stress Scale (DASS-21). This 21-item scale provides independent scores for each of the three psychological states. Higher scores reflect higher levels of distress.
Measured: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
Work Productivity and Activity Impairment
Measured using the Work Productivity and Activity Impairment (WPAI) questionnaire. It evaluates the impact of menstrual pain on work absenteeism, presenteeism, and daily activity impairment. Results are expressed as percentages of impairment.
Measured: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start18 Feb 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther María Pindado Pérez, University of Alcala
- Investigators
- Beatriz Navarro Brazalez, PhD, Study director, Universidad de Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391930
- Sponsor's protocol ID
- EPP-2026
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a High-Intensity Interval Training Program and Analysis of Menstrual Health Experience in Women With Primary Dysmenorrhea: A Mixed-Methods Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07391930
- Acronym / sponsor ID
- EPP-2026
- Conditions
- Dysmenorrhea Primary, Menstrual Pain, Pelvic Pain
- Keywords
- High- Intensity Interval Training, Quality of Life, Menstrual Health, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate whether a 12-week online supervised high-intensity interval training program can reduce menstrual pain and improve quality of life in women with primary dysmenorrhea. Participants will be divided into two groups: one receiving an educational workshop and the HIIT program, and a control group receiving only the workshop. Additionally, the study seeks to understand the personal experience of these women through weekly health diaries, exploring how the intervention affects their relationship with their bodies and their menstruation. The ultimate goal is to offer new, non-pharmacological evidence-based tools for managing menstrual pain.
Detailed description
This research follows a convergent mixed-methods design integrating a randomized controlled trial with a descriptive qualitative study.
Fifty women (aged 18-40) with primary dysmenorrhea will be randomized into two arms:
Experimental Group: 12 weeks of online supervised HIIT (2 sessions/week) plus a menstrual health educational workshop.
Control Group: Menstrual health educational workshop only. Clinical variables (pain intensity via NRS, quality of life via SF-12, and pain characteristics via McGill Questionnaire) will be collected at baseline, 3 months (post-intervention), and 6 months (follow-up).
Simultaneously, all participants will complete a weekly semi-structured digital diary for 12 weeks. These diaries are designed to capture the "thick description" of their menstrual health experience, focusing on the evolution of their relationship with their body and menstruation, perceptions of self-management and empowerment and barriers and facilitators for adherence to the exercise program (in the experimental group).
Following the convergent design, quantitative statistical results will be integrated with the thematic analysis of the diaries. This merging of data will provide a holistic understanding of how high-intensity exercise influences not only physical symptoms but also the biopsychosocial perception of menstrual health in young women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education Workshop | Experimental | Behavioral: Supervised Online HIIT Program, Behavioral: Menstrual Health WorkshopParticipants in this arm will receive a 2-hour online menstrual health education workshop and will perform 2 sessions per week of supervised online High-Intensity Interval Training (HIIT) for 12 weeks. They will also complete weekly qualitative diaries. |
| Menstrual Health Education Workshop | Active comparator | Behavioral: Menstrual Health WorkshopParticipants in this arm will receive the same 2-hour online menstrual health education workshop and will complete the same weekly qualitative diaries, but will not perform the HIIT program during the 12-week study period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- nulliparous
- primary dysmenorrhea
- body mass index between 18 and 30
- menstrual pain >5 according to the Numeric Pain Scale
- exercise >45 minutes/week
Key exclusion criteria (7 listed)
- amenorrhea or cycles >35 days
- secondary dysmenorrhea
- pelvic or abdominal surgical intervention
- use of hormonal drugs
- diagnosed with fibromyalgia, muscoloskeletal injuries or medical comorbidities that prevent them from performing intense exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Online HIIT ProgramThe intervention consists of a total of 24 exercise sessions delivered over 12 weeks (frequency: 2 sessions per week). Each session is conducted online and supervised in real-time by a physical therapist. The 24 sessions follow a structured progression of high-intensity intervals, separated by active recovery periods. | Behavioural | High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education Workshop |
| Menstrual Health WorkshopA 2-hour online educational session covering menstrual cycle physiology, pain neurophysiology, and self-care strategies. This intervention aims to improve menstrual health literacy and provide tools for pain self-management | Behavioural | High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education Workshop, Menstrual Health Education Workshop |
Primary outcome
Change in Menstrual Pain Intensity
Time frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
Measured using the Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will report their peak pain intensity during their menstrual period.
5 secondary outcomes
Health-Related Quality of Life
Time frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
Participant Menstrual Health Experience and Self-Management.
Time frame: Weekly during the 12-week intervention period
Quality of Sleep
Time frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
Levels of Depression, Anxiety, and Stress
Time frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
Work Productivity and Activity Impairment
Time frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatriz Navarro Brazalez, PhD study director
Universidad de Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Online HIIT Program and Menstrual Health Workshop in people with Dysmenorrhea Primary and Menstrual Pain, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther M Pindado Perez, PhD Student (+34 689714447, esther.pindado@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Menstrual Pain Intensity (time frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.