Virtual Menstrual Pain Approaches in Females

NCT07497711 | Recruiting Phase 2 DMC

• 1 other identifier: IRB-2026-042
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain (Visceral, Somatic, or Neuropathic); Women of Reproductive Age; Mental Disorder; Digital Health; Acupressure; Traditional Exercise; Host-Gut Microbiota Interaction; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory-Short Form (BPI-SF)

  BPI-SF is an 11-item pain instrument validated to quantify pain severity (4 items) and pain interference (7 items). It is one of the most widely used instruments to measure pain in patients and has been demonstrated to be a reliable, valid, and responsive measure. BPI worst pain item measures pain at its worst on a 0-10 numeric rating scale, where 0 means no pain at all, and 10 indicates the worst pain imaginable.

  0, 4, 8, 12 Weeks

Secondary Outcomes (9)

• 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

Other Outcomes (2)

• Concentration of small metabolites in plasma (Plasma Metabolome)

  0 & 12 Weeks

• Microbial diversity, evenness, richness, and relative abundance in fecal samples (Gut microbiome)

  0 & 12 Weeks

Study Arms (3)

Virtual Auricular Acupressure

EXPERIMENTAL

A total of 18 sessions of auricular acupressure sessions over 12 weeks, including: (1) Six acupuncturist-led, virtual group training sessions on auricular acupressure; (2) Twelve self-administered, weekly auricular acupressure sessions.

Behavioral: Virtual Auricular Acupressure

Virtual Baduanjin Qigong Exercise

EXPERIMENTAL

A total of 18 sessions of Baduanjin Qigong exercise sessions over 12 weeks, including: (1) Six instructor-led, virtual exercise training sessions on Baduanjin Qigong; (2) Twelve self-administered, weekly Baduanjin Qigong exercise sessions.

Behavioral: Virtual Baduanjin Qigong Exercise

Self Education Control

OTHER

Attention control group with 18 sessions of self education session on menstruation hygiene, including: (1) Six researcher-led, virtual group training sessions on menstrual hygiene; (2) Twelve self-led, weekly menstrual hygiene training sessions.

Behavioral: Self Education

Interventions

Virtual Auricular Acupressure BEHAVIORAL

Virtual auricular acupressure involved acupuncturist-led virtual auricular acupressure treatment and self-administered application in this trial.

Also known as: Auriculoacupressure

Virtual Auricular Acupressure

Virtual Baduanjin Qigong Exercise BEHAVIORAL

Virtual Baduanjin Qigong Exercise involves instructor-led virtual exercise training and self-administered Baduanjin Qigong Exercise in this study.

Also known as: Baduanjin

Virtual Baduanjin Qigong Exercise

Self Education BEHAVIORAL

Attention Control with virtual training on menstrual hygiene and self-led menstrual health education.

Also known as: Attention Control

Self Education Control

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanyang Technological University: lead
• Chengdu University of Traditional Chinese Medicine: collaborator

Study Sites (1)

iHealth Lab, Nanyang Technological University

Singapore, 637550, Singapore

RECRUITING

MeSH Terms

Conditions

Pain; Mental Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mingxiao Yang, MD (CMD), PhD

CONTACT

65+659 21733; mingxiao.yang@ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of iHealth Lab

Model Details: * Auricular Acupressure * Baduanjin Qigong Exercise * Self Education

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): March 20, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

SG (1)