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| Name | Class |
|---|---|
| Chengdu University of Traditional Chinese Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Auricular Acupressure | Behavioral | Virtual auricular acupressure involved acupuncturist-led virtual auricular acupressure treatment and self-administered application in this trial. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 4, 8, 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingxiao Yang, MD (CMD), PhD | Contact | 65+659 21733 | mingxiao.yang@ntu.edu.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iHealth Lab, Nanyang Technological University | Recruiting | Singapore | 637550 | Singapore |
The current IRB approval will allow us to disseminate the study findings with de-identified research data in peer-reviewed academic journals and conferences for presentation.
Share of IPD will require further approval from the IRB committee at our institution and local authorities regulating personal data privacy protection.
We will need to seek their approval for IPD sharing when the complete study data is available, and based on their final assessment and examination of IPD, to share the IPD data.
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| Virtual Baduanjin Qigong Exercise | Behavioral | Virtual Baduanjin Qigong Exercise involves instructor-led virtual exercise training and self-administered Baduanjin Qigong Exercise in this study. |
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| Self Education | Behavioral | Attention Control with virtual training on menstrual hygiene and self-led menstrual health education. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 0, 4, 8, 12 Weeks |
| 0 & 12 Weeks |
| 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. | 0 & 12 Weeks |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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