Effect of Bagua Auriculotherapy on Pain in Patients Undergoing Hysteroscopy

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 Overview

• Status: Active, not recruiting
• Conditions: Procedural Pain
• Intervention / Treatment: Procedure: Paracervical block anesthesia; Procedure: Bagua Auriculotherapy

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • YiWu
    • Zhejiang, YiWu, China, 322000
      • 4th Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paracervical Block Alone Group; Participants receive paracervical block anesthesia (0.1 g lidocaine) as the pain management intervention. No auriculotherapy is administered.	Procedure: Paracervical block anesthesia; The control group received paracervical block anesthesia with 0.1 g lidocaine, without combined Bagua auriculotherapy.
Experimental: Paracervical Block + Bagua Auriculotherapy Group; 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.	Procedure: Paracervical block anesthesia; The control group received paracervical block anesthesia with 0.1 g lidocaine, without combined Bagua auriculotherapy.; Procedure: Bagua Auriculotherapy; 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.
No Intervention: No Anesthesia + No Auriculotherapy Group; Participants receive neither paracervical block anesthesia nor Bagua auriculotherapy during the procedure. Only routine standard care is provided.
Experimental: Bagua Auriculotherapy Alone Group; 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.	Procedure: Bagua Auriculotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the hysteroscopy procedure and up to 30 minutes post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	study enrollment through the post-procedure follow-up period

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Hysteroscopy; Pain Management; Procedural pain; Auricular acupressure; Bagua auriculotherapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Agnosia; Anesthesia and Analgesia; Anesthesia; Anesthesia, Obstetrical
• Other Study ID Numbers: KY-2025-330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No