Procedural Pain
Conditions
Keywords
Bagua auriculotherapy, Auricular acupressure, Procedural pain, Hysteroscopy, Pain Management, Traditional Chinese Medicine
Brief 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 under local anesthesia and those without anesthesia.
Interventions
PROCEDUREParacervical block anesthesia
The control group received paracervical block anesthesia with 0.1 g lidocaine, without combined Bagua auriculotherapy.
PROCEDUREBagua 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.
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity During Hysteroscopy | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Level | 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. |
| Patient Satisfaction | 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. |
| Hemodynamic Parameters | 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. |
| Incidence of Adverse Events | 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. |
Countries
China
Outcome results
None listed