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.
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
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
Parallel
Virtual Auricular Acupressure
BehavioralVirtual auricular acupressure involved acupuncturist-led virtual auricular acupressure treatment and self-administered application in this trial.
Virtual Baduanjin Qigong Exercise
BehavioralVirtual Baduanjin Qigong Exercise involves instructor-led virtual exercise training and self-administered Baduanjin Qigong Exercise in this study.
Self Education
BehavioralAttention Control with virtual training on menstrual hygiene and self-led menstrual health education.
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.
Brief Fatigue Inventory (BFI)
BFI is a reliable 4-item instrument that allows for the rapid assessment of fatigue levels in non-cancer patients with chronic pain, as well as their impact on function over the past 24 hours. The global score ranges from 0 to 10, where 0 indicates no fatigue, and 10 indicates fatigue as bad as you can imagine, with a higher score suggesting worse fatigue.
Pain Catastrophizing Scale (PCS)
PCS is a validated 13-item instrument designed to specifically assess exaggerated negative thoughts and feelings about pain, with three subscales: rumination, magnification, and helplessness. Patients rate items on a 0-4 scale (not at all to all the time) about their response to pain, generating a total score (0-52) indicating the severity of catastrophizing, which helps clinicians identify those at risk for poor outcomes in chronic pain.
Pittsburgh Sleep Quality Index (PSQI)
PSQI is a validated questionnaire that measures sleep quality and disturbances over a one-month recall period. It contains 19 items and measures seven components of sleep quality: subjective sleep quality, sleep latency, sleep efficiency, sleep duration, sleep disturbances, use of sleep medication, and daytime dysfunction. The PSQI global score is the sum of the seven component scores and ranges from 0 to 21, with the higher score indicating worse sleep quality.
Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-item scale with 7 items measuring depression and 7 items measuring anxiety. Each item is answered by the patient on a four-point (0-3) response category, so possible scores range from 0 to 21 for anxiety and depression. Established cutoffs are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Concentration of small metabolites in plasma (Plasma Metabolome)
We will profile all the tentative metabolites in the plasma samples (plasma metabolome) volunteered by study participants. The analytical methods to be used are high-performance liquid chromatography tandomed with mass spectrometry (HPLC-MS). The target metabolites panel includes tryptophan, dopamine, kyurienine and others. Other non-targeted metabolites will also be profiled using HPLC-MS.
Microbial diversity, evenness, richness, and relative abundance in fecal samples (Gut microbiome)
We will use the 16S rRNA sequencing to characterize the microbial species, including the diversity, evenness, richness, and relative abundance of bacteria, in the fecal samples from the participants.
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Nanyang Technological University
Lead sponsor
Chengdu University of Traditional Chinese Medicine
Collaborator
