An interventional study of acupuncture treatment in Pain Vulva, sponsored by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College · Not applicable, Interventional, and Treatment
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.
106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 79 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the experimental group are treated with cheek acupuncture.
Procedure: acupuncture treatment
Patients in the control group are treated with sham acupuncture.
Procedure: 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.
Intraoperative opioid consumption
Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption
Time frame: End of surgery
Patient intravenous controlled analgesia (PCIA) pump consumption
PCIA pump consumption in 24 hours after surgery
Time frame: 24 hours after surgery
the rest numerical rating scale (NRS) scores
0\~11，a higher score means a better outcome
Time frame: 24 hours after surgery, 48 hours after surgery
the coughing numerical rating scale (NRS) scores
0\~11，a higher score means a better outcome
Time frame: 24 hours after surgery, 48 hours after surgery
15-item quality of recovery (QoR-15)
0\~150, a higher score means a better outcome
Time frame: 1 day after surgery, 2 day after surgery
Athens Insomnia Scale (AIS)
0\~24, a lower score means a better outcome
Time frame: 24 hours after surgery, 48 hours after surgery
Hospital Anxiety and Depression Scale（HADS）
HADS(A) and HADS(D), 0\~21, respectively, a lower score means a better outcome
Time frame: 24 hours after surgery, 48 hours after surgery
Patient satisfaction
patient satisfaction on a Likert scale (1\~5,a higher score means a better satisfaction)
Time frame: 48 hours after surgery
Systolic blood pressure (SBP)
Intraoperative hemodynamics
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Diastolic blood pressure (DBP)
Intraoperative hemodynamics
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Mean blood pressure (MBP)
Intraoperative hemodynamics
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Heart rate (HR)
Intraoperative hemodynamics
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Opioid-related side effects
postoperative nausea and vomiting (PONV), dizziness, headache, pruritus, and respiratory depression
Time frame: 0~48 hours after surgery
Acupuncture-related side effects
hematoma，infection
Time frame: 0~48 hours after surgery
Intraoperative dexmedetomidine consumption
Time frame: End of surgery
Intraoperative midazolam consumption
Time frame: End of surgery
Respiratory rates (RR)
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
the partial pressure of end-tidal carbon dioxide (PetCO2)
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College