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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracervical Block Alone Group | Active Comparator | Participants receive paracervical block anesthesia (0.1 g lidocaine) as the pain management intervention. No auriculotherapy is administered. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracervical block anesthesia | Procedure | The control group received paracervical block anesthesia with 0.1 g lidocaine, without combined Bagua auriculotherapy. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4th Affiliated Hospital, School of Medicine, Zhejiang University, China | Zhejiang | YiWu | 322000 | China |
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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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000773 | Anesthesia, Obstetrical |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| 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. |
|
| 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 |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |