Application of Cheek Acupuncture in Vaginal Tightening Surgery

NCT ID: NCT06587711

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-02-28

Brief Summary

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A large number of studies have shown that acupuncture can reduce perioperative pain in patients. Cheek acupuncture therapy is a new acupuncture treatment, which belongs to the microneedle system, that is, acupuncture at specific acupoint on the face, which can relieve patients' pain. In this study, the efficacy and safety of cheek acupuncture in patients undergoing vaginal tightening surgery was verified by observing the consumption of opioid, intraoperative hemodynamics, dosage of oral remedial analgesics, postoperative quality of recovery, patient satisfaction, incidence of side effects, etc.

Detailed Description

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Conditions

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Pain Vulva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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cheek acupuncture treatmnet

Patients in the experimental group are treated with cheek acupuncture.

Group Type EXPERIMENTAL

acupuncture treatment

Intervention Type PROCEDURE

Patients in experimental group received acupuncture at specific acupoint on the face, patients in control group received sham acupuncture at non-acupoint on the face.

sham acupuncture treatment

Patients in the control group are treated with sham acupuncture.

Group Type SHAM_COMPARATOR

acupuncture treatment

Intervention Type PROCEDURE

Patients in experimental group received acupuncture at specific acupoint on the face, patients in control group received sham acupuncture at non-acupoint on the face.

Interventions

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acupuncture treatment

Patients in experimental group received acupuncture at specific acupoint on the face, patients in control group received sham acupuncture at non-acupoint on the face.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-60 years, undergoing vaginal tightening surgery
* American Society of Anesthesiologists (ASA) physical status I to II
* Voluntary participation and signed an informed consent form

Exclusion Criteria

* Acute and/or chronic pain before surgery
* History of congenital heart disease, arrhythmia, or hypertension
* History of severe mental or neurological diseases, drug or psychotropic drug abuse
* Cognitive dysfunction or inability to communicate.
* The acupuncture acupoints are infected
* Coagulation disorders
* Patients with mandibular or zygomatic bone osteotomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

OTHER

Sponsor Role lead

Responsible Party

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Chunmei Chen

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Dong, doctorate

Role: STUDY_CHAIR

Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Locations

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Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Chen Chunmei, doctorate

Role: CONTACT

+8618611612186

Facility Contacts

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Deng Xiaoming, master

Role: primary

+8618618158087

Other Identifiers

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PlasticSurgeryHPecking

Identifier Type: -

Identifier Source: org_study_id

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