Health TrialsbyHealthPanel

High-Intensity Interval Training and Menstrual Health Experience in Primary Dysmenorrhea.

ConditionsDysmenorrhea PrimaryMenstrual PainPelvic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity of Alcala

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

nulliparous

primary dysmenorrhea

body mass index between 18 and 30

menstrual pain >5 according to the Numeric Pain Scale

Disqualifiers

amenorrhea or cycles >35 days

secondary dysmenorrhea

pelvic or abdominal surgical intervention

use of hormonal drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Supervised Online HIIT Program

    Behavioral

    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 Workshop

    Behavioral

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education WorkshopExperimental treatment 2 interventions
Group B: Menstrual Health Education WorkshopActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)

Secondary outcomes

1

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.

Time frame
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
2

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.

Time frame
Weekly during the 12-week intervention period
3

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.

Time frame
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
4

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.

Time frame
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alcala

Lead sponsor

Source ClinicalTrials.gov
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