Virtual Auricular Acupressure and Baduanjin Qigong Exercise for Preventing Menstrual Pain in Females: A Randomized Clinical Trial

Plain English Summary

Virtual Menstrual Pain Approaches in Females is a Phase 3 clinical trial sponsored by Nanyang Technological University studying Pain (Visceral, Somatic, or Neuropathic), Women of Reproductive Age, Mental Disorder, Digital Health, Acupressure, Traditional Exercise, Host-Gut Microbiota Interaction, Metabolomics. Tests two self-care methods to prevent or reduce menstrual pain in young women. For women aged 16-35 with regular menstrual cycles and primary dysmenorrhea. Participation involves 12 weeks of online training and self-practice of acupressure or qigong. Alternative treatments include over-the-counter pain relievers and lifestyle changes. The trial aims to enroll 145 participants.

Official Summary

This research study is testing two self-care approaches that may help prevent or reduce period pain in young females with primary dysmenorrhea, a common condition that causes painful menstrual cramps. Participants will be placed by chance into 1 of 3 groups: auricular acupressure, Baduanjin qigong, or a self-care education comparison group. The auricular acupressure and Baduanjin groups will receive online training and then practice the treatment on their own for 12 weeks. The main question is whether these two approaches can reduce the severity of menstrual pain. The study will also look at whether they can improve other symptoms that often happen with period pain, such as tiredness, poor sleep, anxiety, low mood, trouble concentrating, and reduced physical function. Researchers will also study stool and blood-related biological markers to better understand whether changes in gut bacteria and body metabolism may be linked to symptom improvement. A total of 145 participants will take part in the study at NTU, and any side effects or other safety concerns will be checked every week.

Who Can Participate

Here is what you need to know about eligibility for this trial. Ages 16-35, regular menstrual cycles, confirmed primary dysmenorrhea, willing to comply with study procedures. Excluded if have uncontrolled neurological diseases, immunodeficiency, bleeding disorders, or are pregnant. Must be able to use digital content and understand the study. Requires a medical certificate from a primary care physician. This trial is studying Pain (Visceral, Somatic, or Neuropathic), Women of Reproductive Age, Mental Disorder, Digital Health, Acupressure, Traditional Exercise, Host-Gut Microbiota Interaction, Metabolomics, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures pain levels, which can help patients understand if these methods reduce menstrual cramps and related symptoms. The specific primary outcome measures are: Brief Pain Inventory-Short Form (BPI-SF) (0, 4, 8, 12 Weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial fills a gap by testing non-invasive, self-care methods to manage menstrual pain, offering alternatives to traditional pain management. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Pain (Visceral, Somatic, or Neuropathic), Women of Reproductive Age, Mental Disorder, Digital Health, Acupressure, Traditional Exercise, Host-Gut Microbiota Interaction, Metabolomics, where improved treatment options are needed.

Investor Insight

Market size is significant given the prevalence of dysmenorrhea, with a competitive landscape focusing on digital health solutions. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if you have regular menstrual cycles and primary dysmenorrhea. Participation involves 12 weeks of online training and self-practice of acupressure or qigong. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 145 participants

Interventions

• BEHAVIORAL: Virtual Auricular Acupressure — Virtual auricular acupressure involved acupuncturist-led virtual auricular acupressure treatment and self-administered application in this trial.
• BEHAVIORAL: Virtual Baduanjin Qigong Exercise — Virtual Baduanjin Qigong Exercise involves instructor-led virtual exercise training and self-administered Baduanjin Qigong Exercise in this study.
• BEHAVIORAL: Self Education — Attention Control with virtual training on menstrual hygiene and self-led menstrual health education.

Primary Outcomes

• Brief Pain Inventory-Short Form (BPI-SF) (0, 4, 8, 12 Weeks)

Secondary Outcomes

• Brief Fatigue Inventory (BFI) (0, 4, 8, 12 Weeks)
• Pain Catastrophizing Scale (PCS) (0, 4, 8, 12 weeks)
• Pittsburgh Sleep Quality Index (PSQI) (0, 4, 8, 12 Weeks)
• Hospital Anxiety and Depression Scale (HADS) (0, 4, 8, 12 weeks)
• Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-Global) (0, 4, 8, 12 Weeks)

Full Eligibility Criteria

Inclusion Criteria:

* 16 - 35 years of age
* Regular menstrual cycles (28 days ± 7 days) in 3 months prior to enrollment
* Primary dysmenorrhea confirmed by a study clinician or the participant's primary care doctor
* Two or more episodes of menstrual cramps in the past 2 months, scored at least 4 points on the worst pain item of the Brief Pain Inventory (BPI)
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Ability to download, install, and navigate the study-specific digital content and use its core functions for training, self-guided intervention administration, and data entry
* Ability to understand the nature of the study and willingness to give informed consent.

Note: Patients are required to submit a medical certificate from their primary care physician documenting a clinical diagnosis of primary dysmenorrhea.

Exclusion Criteria:

* Uncontrolled neurological diseases, immunodeficiency, bleeding disorders, and allergies
* The presence of another Axis I disorder not in remission
* Lactating or pregnant, or those planning to become pregnant in the coming half year
* Undergoing other trials for pain management during the study period
* Plan to initiate other pain therapies for menstrual pain management in the proceeding 3 months

Trial Locations

• iHealth Lab, Nanyang Technological University, Singapore, Singapore

Frequently Asked Questions

Related Conditions

• Conditions: Primary dysmenorrhea, menstrual pain, mental health, and digital health.
• Therapeutic areas: Pain management, women's health, and digital health interventions.

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