Virtual Menstrual Pain Approaches in Females

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age16-35
SponsorNanyang Technological University

About this trial

This research study is testing two self-care approaches that may help prevent or reduce period pain in young females with recurrent 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.

Eligibility criteria

Qualifiers

16 - 35 years of age

Regular menstrual cycles (28 days ± 7 days) in 3 months prior to enrollment

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Virtual Auricular Acupressure
  • Virtual Baduanjin Qigong Exercise
  • Self Education

Treatment groups

145 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Nanyang Technological University

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Collaborator