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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
145
Virtual auricular acupressure involved acupuncturist-led virtual auricular acupressure treatment and self-administered application in this trial.
Virtual Baduanjin Qigong Exercise involves instructor-led virtual exercise training and self-administered Baduanjin Qigong Exercise in this study.
Attention Control with virtual training on menstrual hygiene and self-led menstrual health education.
iHealth Lab, Nanyang Technological University
Singapore, Singapore
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.
Time frame: 0, 4, 8, 12 Weeks
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.
Time frame: 0, 4, 8, 12 Weeks
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.
Time frame: 0, 4, 8, 12 weeks
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.
Time frame: 0, 4, 8, 12 Weeks
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.
Time frame: 0, 4, 8, 12 weeks
Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-Global)
PROMIS-Global is a brief instrument composed of 10 items that demonstrates adequate reliability and validity as a measure of health-related QOL in general and clinical populations. Patients are asked to respond to questions 1-8 and 10 on a scale of 1-5. Question 9 is on a 0-10 scale (average pain rating). The measure yields two scores, physical health and mental health, with higher scores indicating better physical and mental health.
Time frame: 0, 4, 8, 12 Weeks
Stroop Color and Word Test (SCWT)
SCWT is a validated interactive neuropsychological test to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. It has been used to measure cognitive capacity and performance when neuropathic or visceral pain exists as a distraction and interferes congition. SCWT measures cognitive flexibility and attention by scoring the number of correct responses (raw score) in 45 seconds for three tasks: word reading (W), color naming (C), and conflicting color-word (CW) naming. A higher interference score or lower T-score (below 40) generally indicates stronger interference, potential cognitive impairment, or reading disabilities, whereas high raw scores on the CW task suggest better inhibition.
Time frame: 0, 4, 8, 12 Weeks
Patient-Reported Outcomes Measurement Information System-Self-Reported Measure of Physical Function (PROMIS-Physical Function)
PROMIS-Physical Function (Short Form, v2.0, 10a) is a validated 10-item instrument to measure overall physical function and performance among people with different pain conditions, i.e., rheumatoid arthritis and back pain. Items are rated on a 5-point scale (1-No difficulty to 5-Unable to do), with lower total raw scores indicating better function. Results are converted to a T-score (mean=50, SD=10), where higher T-scores indicate better physical function.
Time frame: 0, 4, 8, 12 Weeks
Pain Medication Use
Pain Medication Diary will be used to closely track the use of any painkillers for pain relief during the entire trial period. The name and dose of the drug, time of administration, and pain relief will be closely recorded in the pain medication diary.
Time frame: 0, 4, 8, 12 Weeks
Pain Diary
Pain Diary will be used to track the number of menstrual pain attacks, pain severity on a 0-10 numeric rating scale, and the duration of pain (starting time and resolving time).
Time frame: 0, 4, 8, 12 Weeks
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