Virtual Menstrual Pain Approaches in Females

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.