Procedural PainNCT07512791
Effect of Bagua Auriculotherapy on Pain in Patients Undergoing Hysteroscopy
A study testing Paracervical block anesthesia and Bagua Auriculotherapy in people with Procedural Pain, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
To investigate the application of Bagua ear therapy as an adjunctive intervention for perioperative pain management in patients undergoing hysteroscopic surgery, to analyze its effects on intraoperative and postoperative pain, and to compare the differences in pain outcomes between patients undergoing hysteroscopy… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Paracervical block anesthesia and Bagua Auriculotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 20 to 45 years
- Female
- Scheduled for diagnostic hysteroscopy
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II
- Normal comprehension and communication skills, able to complete Numerical Rating Scale (NRS) and Self-Rating Anxiety Scale (SAS) assessments
- Willing to provide written informed consent
Who cannot join
- Known allergy to auricular plaster or Vaccaria segetalis (Wang Bu Liu Xing) seeds
- Active lesions on the ear, such as wounds, ulcers, swelling, or deformity
- Severe psychiatric or neurological disorders
- Severe cardiovascular or cerebrovascular diseases
- Pre-existing significant pain, nausea, vomiting, dizziness, or tinnitus before the procedure
Trial locations and contacts
1 site in 1 country.
China1 site
4th Affiliated Hospital, School of Medicine, Zhejiang University, China
Zhejiang, YiWu, 322000
About this study
To investigate the application of Bagua ear therapy as an adjunctive intervention for perioperative pain management in patients undergoing hysteroscopic surgery, to analyze its effects on intraoperative and postoperative pain, and to compare the differences in pain outcomes between patients undergoing hysteroscopy under local anesthesia and those without anesthesia.
- Conditions
- Procedural Pain
- Being tested
- Paracervical block anesthesia, Bagua Auriculotherapy
- Keywords
- Bagua auriculotherapy, Auricular acupressure, Procedural pain, Hysteroscopy, Pain Management, Traditional Chinese Medicine
- Medical subject headings
- Pain, Procedural, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracervical block anesthesiaProcedure or surgery
The control group received paracervical block anesthesia with 0.1 g lidocaine, without combined Bagua auriculotherapy.
Bagua AuriculotherapyProcedure or surgery
For the intervention, Vaccaria seeds were attached to selected auricular points using adhesive tape. The auricular skin was disinfected with 75% alcohol wipes. According to Bagua theory, the seeds were placed at the Kan, Li, Gen, and Qian positions, localized based on the Group Standard of Guangdong Provincial Association of Traditional Chinese Medicine (T/GDACM0143-2025): "Bagua Auriculotherapy Localization and Compatibility". Manual pressure was applied using the thumb and index finger pads on each point. The pressing procedure commenced 15 minutes before surgery, with each point pressed 30 times in the sequence of Kan, Li, Gen, and Qian, repeated for three cycles, until sensations of warmth, pain, numbness, or distension were achieved. Immediately after surgical incision, each point was pressed 30 times following the same sequence for three cycles, and immediately after surgery completion, each point was again pressed 30 times for three cycles.
| Study group | Role | What they receive |
|---|---|---|
| Paracervical Block Alone Group | Active comparator | Participants receive paracervical block anesthesia (0.1 g lidocaine) as the pain management intervention. No auriculotherapy is administered. Receives: Procedure: Paracervical block anesthesia |
| Paracervical Block + Bagua Auriculotherapy Group | Experimental | Participants receive both paracervical block anesthesia (0.1 g lidocaine) and Bagua auriculotherapy. The auriculotherapy is administered by a trained practitioner starting 15 minutes before surgery and continuing until 30 minutes after the procedure. Receives: Procedure: Paracervical block anesthesia; Procedure: Bagua Auriculotherapy |
| No Anesthesia + No Auriculotherapy Group | No intervention | Participants receive neither paracervical block anesthesia nor Bagua auriculotherapy during the procedure. Only routine standard care is provided. |
| Bagua Auriculotherapy Alone Group | Experimental | Participants receive Bagua auriculotherapy without paracervical block anesthesia. The therapy is administered by a trained practitioner starting 15 minutes before surgery and continuing until 30 minutes after the procedure. Receives: Procedure: Bagua Auriculotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Hysteroscopy
Pain intensity measured using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Assessments are performed at five time points: during vaginal disinfection, at hysteroscope insertion, during the procedure, at procedure completion, and 30 minutes post-procedure.
Measured: During the hysteroscopy procedure and up to 30 minutes post-procedure
Secondary outcomes (4)
Anxiety Level
Anxiety assessed using the Self-Rating Anxiety Scale (SAS). The SAS consists of 20 items, each scored on a 4-point Likert scale (1 to 4). Standard scores range from 20 to 80, with higher scores indicating greater anxiety. A score of 50 or higher indicates clinically significant anxiety.
Measured: before the procedure
Patient Satisfaction
Patient satisfaction with the procedure assessed using a self-administered 5-point Likert scale: 5 = very satisfied, 4 = satisfied, 3 = neutral, 2 = dissatisfied, 1 = very dissatisfied.
Measured: After the procedure, before discharge
Hemodynamic Parameters
Heart rate (beats per minute) and blood pressure (systolic and diastolic, mmHg) recorded at four time points: during vaginal disinfection, at hysteroscope insertion, during the procedure, and at procedure completion.
Measured: During the hysteroscopy procedure
Incidence of Adverse Events
Number of participants experiencing adverse events, including auricular site reactions (pain, pruritus, erythema, swelling, bleeding, bruising, contact dermatitis) and any other unexpected medical events occurring during the study period.
Measured: study enrollment through the post-procedure follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Mar 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512791
- Sponsor's protocol ID
- KY-2025-330
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including demographic data, baseline characteristics, primary and secondary outcome measures, adverse events, and other key study variables as reported in the article text, tables, figures, and appendices.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bagua Auriculotherapy on Pain in Patients Undergoing Hysteroscopy
- ClinicalTrials.gov ID
- NCT07512791
- Acronym / sponsor ID
- KY-2025-330
- Conditions
- Procedural Pain
- Keywords
- Bagua auriculotherapy, Auricular acupressure, Procedural pain, Hysteroscopy, Pain Management, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Apr 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.
To investigate the application of Bagua ear therapy as an adjunctive intervention for perioperative pain management in patients undergoing hysteroscopic surgery, to analyze its effects on intraoperative and postoperative pain, and to compare the differences in pain outcomes between patients undergoing hysteroscopy under local anesthesia and those without anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Paracervical Block Alone Group | Active comparator | Procedure: Paracervical block anesthesiaParticipants receive paracervical block anesthesia (0.1 g lidocaine) as the pain management intervention. No auriculotherapy is administered. |
| Paracervical Block + Bagua Auriculotherapy Group | Experimental | Procedure: Paracervical block anesthesia, Procedure: Bagua AuriculotherapyParticipants receive both paracervical block anesthesia (0.1 g lidocaine) and Bagua auriculotherapy. The auriculotherapy is administered by a trained practitioner starting 15 minutes before surgery and continuing until 30 minutes after the procedure. |
| No Anesthesia + No Auriculotherapy Group | No intervention | –Participants receive neither paracervical block anesthesia nor Bagua auriculotherapy during the procedure. Only routine standard care is provided. |
| Bagua Auriculotherapy Alone Group | Experimental | Procedure: Bagua AuriculotherapyParticipants receive Bagua auriculotherapy without paracervical block anesthesia. The therapy is administered by a trained practitioner starting 15 minutes before surgery and continuing until 30 minutes after the procedure. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 20 to 45 years
- Female
- Scheduled for diagnostic hysteroscopy
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II
- Normal comprehension and communication skills, able to complete Numerical Rating Scale (NRS) and Self-Rating Anxiety Scale (SAS) assessments
Key exclusion criteria (5 listed)
- Known allergy to auricular plaster or Vaccaria segetalis (Wang Bu Liu Xing) seeds
- Active lesions on the ear, such as wounds, ulcers, swelling, or deformity
- Severe psychiatric or neurological disorders
- Severe cardiovascular or cerebrovascular diseases
- Pre-existing significant pain, nausea, vomiting, dizziness, or tinnitus before the procedure
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 |
|---|---|---|
| Paracervical block anesthesiaThe control group received paracervical block anesthesia with 0.1 g lidocaine, without combined Bagua auriculotherapy. | Procedure or surgery | Paracervical Block + Bagua Auriculotherapy Group, Paracervical Block Alone Group |
| Bagua AuriculotherapyFor the intervention, Vaccaria seeds were attached to selected auricular points using adhesive tape. The auricular skin was disinfected with 75% alcohol wipes. According to Bagua theory, the seeds were placed at the Kan, Li, Gen, and Qian positions, localized based on the Group Standard of Guangdong Provincial Association of Traditional Chinese Medicine (T/GDACM0143-2025): "Bagua Auriculotherapy Localization and Compatibility". Manual pressure was applied using the thumb and index finger pads on each point. The pressing procedure commenced 15 minutes before surgery, with each point pressed 30 times in the sequence of Kan, Li, Gen, and Qian, repeated for three cycles, until sensations of warmth, pain, numbness, or distension were achieved. Immediately after surgical incision, each point was pressed 30 times following the same sequence for three cycles, and immediately after surgery completion, each point was again pressed 30 times for three cycles. | Procedure or surgery | Bagua Auriculotherapy Alone Group, Paracervical Block + Bagua Auriculotherapy Group |
Primary outcome
Pain Intensity During Hysteroscopy
Time frame: During the hysteroscopy procedure and up to 30 minutes post-procedure
Pain intensity measured using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Assessments are performed at five time points: during vaginal disinfection, at hysteroscope insertion, during the procedure, at procedure completion, and 30 minutes post-procedure.
4 secondary outcomes
Anxiety Level
Time frame: before the procedure
Patient Satisfaction
Time frame: After the procedure, before discharge
Hemodynamic Parameters
Time frame: During the hysteroscopy procedure
Incidence of Adverse Events
Time frame: study enrollment through the post-procedure follow-up period
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 6 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including demographic data, baseline characteristics, primary and secondary outcome measures, adverse events, and other key study variables as reported in the article text, tables, figures, and appendices.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracervical block anesthesia and Bagua Auriculotherapy in people with Procedural Pain, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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 China. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity During Hysteroscopy (time frame: During the hysteroscopy procedure and up to 30 minutes post-procedure). 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 6 Apr 2026.