Virtual Menstrual Pain Approaches in Females
NCT07497711, Phase 2, Phase 3, Recruiting, Nanyang Technological University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Virtual Menstrual Pain Approaches in Females | ClinicalTrials.gov |
| NCT number | NCT07497711 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 145 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Nanyang Technological University | ClinicalTrials.gov |
| Conditions | Pain (Visceral, Somatic, or Neuropathic), Women of Reproductive Age, Mental Disorder, Digital Health, Acupressure, Traditional Exercise, Host-Gut Microbiota Interaction, Metabolomics | ClinicalTrials.gov |
| Interventions | Virtual Auricular Acupressure, Virtual Baduanjin Qigong Exercise, Self Education | ClinicalTrials.gov |
| First posted | 2026-03-27 | ClinicalTrials.gov |
| Last updated | 2026-06-23 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Brief Pain Inventory-Short Form (BPI-SF) | 0, 4, 8, 12 Weeks | 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. | ClinicalTrials.gov |
| Secondary | Brief Fatigue Inventory (BFI) | 0, 4, 8, 12 Weeks | 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. | ClinicalTrials.gov |
| Secondary | Pain Catastrophizing Scale (PCS) | 0, 4, 8, 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | 0, 4, 8, 12 Weeks | 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. | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | 0, 4, 8, 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-Global) | 0, 4, 8, 12 Weeks | 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. | ClinicalTrials.gov |
| Secondary | Stroop Color and Word Test (SCWT) | 0, 4, 8, 12 Weeks | 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. | ClinicalTrials.gov |
| Secondary | Patient-Reported Outcomes Measurement Information System-Self-Reported Measure of Physical Function (PROMIS-Physical Function) | 0, 4, 8, 12 Weeks | 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. | ClinicalTrials.gov |
| Secondary | Pain Medication Use | 0, 4, 8, 12 Weeks | 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. | ClinicalTrials.gov |
| Secondary | Pain Diary | 0, 4, 8, 12 Weeks | 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). | ClinicalTrials.gov |
| Other | Concentration of small metabolites in plasma (Plasma Metabolome) | 0 & 12 Weeks | 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. | ClinicalTrials.gov |
| Other | Microbial diversity, evenness, richness, and relative abundance in fecal samples (Gut microbiome) | 0 & 12 Weeks | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)