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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
Virtual Auricular Acupressure, Virtual Baduanjin Qigong Exercise and Self Education
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.

Mingxiao Yang, MD (CMD), PhD contact

65+659 21733

mingxiao.yang@ntu.edu.sg

Singapore1 site, 1 recruiting
  • iHealth Lab, Nanyang Technological University

    Singapore, 637550

    Mingxiao Yang, 65-659 21733, mingxiao.yang@ntu.edu.sg

    Recruiting

Other trials in Singapore

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.

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 groups in NCT07497711
Study groupRoleWhat they receive
Virtual Auricular AcupressureExperimentalA 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 ExerciseExperimentalA 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 ControlOtherAttention 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted27 Mar 2026
  2. Study start15 Apr 2026
  3. Primary completion20 Dec 2028 (estimated)
  4. Study completion20 Mar 2029 (estimated)

Resources

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)
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.

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.

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