Effect of Bagua Auriculotherapy on Pain in Patients Undergoing Hysteroscopy

N/AActive Not RecruitingNCT07512791

The Fourth Affiliated Hospital of Zhejiang University School of Medicine132 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

132

Conditions

Procedural Pain

Interventions

Paracervical block anesthesiaPROCEDURE

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

Bagua AuriculotherapyPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Zhejiang, YiWu, China

Outcomes

Primary Outcomes

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.

Time frame: During the hysteroscopy procedure and up to 30 minutes post-procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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