Virtual Menstrual Pain Approaches in Females (AABQ)

Nanyang Technological University

Status and phase: Not yet enrolling; Phase 3; Phase 2

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

Treatments: Behavioral: Virtual Baduanjin Qigong Exercise; Behavioral: Virtual Auricular Acupressure; Behavioral: Self Education

Study type: Interventional

Funder types: Other

Identifiers

NCT07497711

IRB-2026-042

Details and patient eligibility

About

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.

Enrollment: 145 estimated patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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145 participants in 3 patient groups

Virtual Auricular Acupressure

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Auricular Acupressure

Virtual Baduanjin Qigong Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Baduanjin Qigong Exercise

Self Education Control

Other group

Description:

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.

Treatment:

Behavioral: Self Education