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NCT Number: NCT07512791

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Procedural Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

4th Affiliated Hospital, School of Medicine, Zhejiang University, China

Zhejiang, YiWu, 322000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracervical block anesthesia

Procedure

The control group received paracervical block anesthesia with 0.1 g lidocaine, without combined Bagua auriculotherapy.

Bagua Auriculotherapy

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Anxiety Level

    Time frame: before the procedure

    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.

  2. Patient Satisfaction

    Time frame: After the procedure, before discharge

    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.

  3. Hemodynamic Parameters

    Time frame: During the hysteroscopy procedure

    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.

  4. Incidence of Adverse Events

    Time frame: study enrollment through the post-procedure follow-up period

    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.

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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