Pain (Visceral, Somatic, or Neuropathic)Phase 2/3AABQNCT07497711
Virtual Menstrual Pain Approaches in Females
A Phase 2/3 study testing Virtual Auricular Acupressure, Virtual Baduanjin Qigong Exercise and Self Education in people with Pain (Visceral, Somatic, or Neuropathic) and Women of Reproductive Age, run by Nanyang Technological University at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Pain (Visceral, Somatic, or Neuropathic), Women of Reproductive Age, Mental Disorder
- What is being tested?
- Virtual Auricular Acupressure, Virtual Baduanjin Qigong Exercise and Self Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Apr 2026to 20 Mar 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Ability to download, install, and navigate the study-specific digital content and use its core functions for training, self-guided intervention administration, and data entry
- Ability to understand the nature of the study and willingness to give informed consent.
Who cannot join
- 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
- Plan to initiate other pain therapies for menstrual pain management in the proceeding 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
iHealth Lab, Nanyang Technological University
Singapore, 637550
Mingxiao Yang, 65-659 21733, mingxiao.yang@ntu.edu.sg
About this study
Official title: Virtual Auricular Acupressure and Baduanjin Qigong Exercise for Preventing Menstrual Pain in Females: A Randomized Clinical Trial
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.
- Conditions
- Pain (Visceral, Somatic, or Neuropathic), Women of Reproductive Age, Mental Disorder, Digital Health, Acupressure, Traditional Exercise
- Being tested
- Virtual Auricular Acupressure, Virtual Baduanjin Qigong Exercise, Self Education
- Medical subject headings
- Pain, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Auricular AcupressureBehavioural
Also called Auriculoacupressure
Virtual auricular acupressure involved acupuncturist-led virtual auricular acupressure treatment and self-administered application in this trial.
Virtual Baduanjin Qigong ExerciseBehavioural
Also called Baduanjin
Virtual Baduanjin Qigong Exercise involves instructor-led virtual exercise training and self-administered Baduanjin Qigong Exercise in this study.
Self EducationBehavioural
Also called Attention Control
Attention Control with virtual training on menstrual hygiene and self-led menstrual health education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Auricular Acupressure |
| 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. Receives: Behavioral: Virtual Baduanjin Qigong Exercise |
| 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. Receives: Behavioral: Self Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 4, 8, 12 Weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 0, 4, 8, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Apr 2026
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain (Visceral, Somatic, or Neuropathic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Auricular Acupressure * Baduanjin Qigong Exercise * Self Education
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Yang Mingxiao, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497711
- Sponsor's protocol ID
- IRB-2026-042
- Acronym
- AABQ
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Auricular Acupressure and Baduanjin Qigong Exercise for Preventing Menstrual Pain in Females: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07497711
- Acronym / sponsor ID
- AABQ / IRB-2026-042
- Conditions
- Pain (Visceral, Somatic, or Neuropathic), Women of Reproductive Age, Mental Disorder, Digital Health, Acupressure, Traditional Exercise
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Mar 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- * Auricular Acupressure * Baduanjin Qigong Exercise * Self Education
| Arm | Type | Receives |
|---|---|---|
| Virtual Auricular Acupressure | Experimental | Behavioral: Virtual Auricular AcupressureA 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. |
| Virtual Baduanjin Qigong Exercise | Experimental | Behavioral: Virtual Baduanjin Qigong ExerciseA 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. |
| Self Education Control | Other | Behavioral: Self EducationAttention 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. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
- Ability to download, install, and navigate the study-specific digital content and use its core functions for training, self-guided intervention administration, and data entry
Key exclusion criteria (5 listed)
- 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
- Plan to initiate other pain therapies for menstrual pain management in the proceeding 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Auricular AcupressureAlso: AuriculoacupressureVirtual auricular acupressure involved acupuncturist-led virtual auricular acupressure treatment and self-administered application in this trial. | Behavioural | Virtual Auricular Acupressure |
| Virtual Baduanjin Qigong ExerciseAlso: BaduanjinVirtual Baduanjin Qigong Exercise involves instructor-led virtual exercise training and self-administered Baduanjin Qigong Exercise in this study. | Behavioural | Virtual Baduanjin Qigong Exercise |
| Self EducationAlso: Attention ControlAttention Control with virtual training on menstrual hygiene and self-led menstrual health education. | Behavioural | Self Education Control |
Primary outcome
Brief Pain Inventory-Short Form (BPI-SF)
Time frame: 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.
9 secondary outcomes
Brief Fatigue Inventory (BFI)
Time frame: 0, 4, 8, 12 Weeks
Pain Catastrophizing Scale (PCS)
Time frame: 0, 4, 8, 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 0, 4, 8, 12 Weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 0, 4, 8, 12 weeks
Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-Global)
Time frame: 0, 4, 8, 12 Weeks
Stroop Color and Word Test (SCWT)
Time frame: 0, 4, 8, 12 Weeks
Patient-Reported Outcomes Measurement Information System-Self-Reported Measure of Physical Function (PROMIS-Physical Function)
Time frame: 0, 4, 8, 12 Weeks
Pain Medication Use
Time frame: 0, 4, 8, 12 Weeks
Pain Diary
Time frame: 0, 4, 8, 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Pain (Visceral, Somatic, or Neuropathic)
Recruiting
Post Operative Pain and Vagal Stimulation
Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic)
Not yet recruiting
The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients
Pain (Visceral, Somatic, or Neuropathic), Anxiety Acute
RecruitingObservational study
Characteristics of Persistent Pain Composition Following Total Hip or Knee Arthroplasty: a Descriptive Study
Pain (Visceral, Somatic, or Neuropathic), Hip Arthroplasty Replacement
Recruiting
Comparison of Conventional Buccal Nerve Block Versus Buccal Nerve Trunk Block During Extraction of Posterior Mandibular Teeth
Pain (Visceral, Somatic, or Neuropathic)
Recruiting
Distolingual Infiltration Verses Conventional Nerve Block in Mandibular Third Molar Extraction
Pain (Visceral, Somatic, or Neuropathic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Virtual Auricular Acupressure, Virtual Baduanjin Qigong Exercise and Self Education in people with Pain (Visceral, Somatic, or Neuropathic) and Women of Reproductive Age, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingxiao Yang, MD (CMD), PhD (65+659 21733, mingxiao.yang@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory-Short Form (BPI-SF) (time frame: 0, 4, 8, 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.