Pain VulvaNCT06587711
Application of Cheek Acupuncture in Vaginal Tightening Surgery
A study testing acupuncture treatment in people with Pain Vulva, run by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pain Vulva
- What is being tested?
- acupuncture treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 010
Deng Xiaoming, master, +8618618158087, zhengxingmazui@163.com
About this study
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.
- Conditions
- Pain Vulva
- Being tested
- acupuncture treatment
- Keywords
- Acupuncture, Analgesia, Vaginal tighting surgery
- Medical subject headings
- Vulvodynia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| cheek acupuncture treatmnet | Experimental | Patients in the experimental group are treated with cheek acupuncture. Receives: Procedure: acupuncture treatment |
| sham acupuncture treatment | Sham comparator | Patients in the control group are treated with sham acupuncture. Receives: Procedure: acupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative opioid consumption
Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption
Measured: End of surgery
Secondary outcomes (17)
Patient intravenous controlled analgesia (PCIA) pump consumption
PCIA pump consumption in 24 hours after surgery
Measured: 24 hours after surgery
the rest numerical rating scale (NRS) scores
0~11，a higher score means a better outcome
Measured: 24 hours after surgery, 48 hours after surgery
the coughing numerical rating scale (NRS) scores
0~11，a higher score means a better outcome
Measured: 24 hours after surgery, 48 hours after surgery
15-item quality of recovery (QoR-15)
0~150, a higher score means a better outcome
Measured: 1 day after surgery, 2 day after surgery
Athens Insomnia Scale (AIS)
0~24, a lower score means a better outcome
Measured: 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
Measured: 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)
Measured: 48 hours after surgery
Systolic blood pressure (SBP)
Intraoperative hemodynamics
Measured: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Diastolic blood pressure (DBP)
Intraoperative hemodynamics
Measured: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Mean blood pressure (MBP)
Intraoperative hemodynamics
Measured: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Heart rate (HR)
Intraoperative hemodynamics
Measured: 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
Measured: 0~48 hours after surgery
Acupuncture-related side effects
hematoma，infection
Measured: 0~48 hours after surgery
Intraoperative dexmedetomidine consumption
Measured: End of surgery
Intraoperative midazolam consumption
Measured: End of surgery
Respiratory rates (RR)
Measured: 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)
Measured: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain VulvaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunmei Chen, The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Investigators
- Yang Dong, doctorate, Study chair, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587711
- Sponsor's protocol ID
- PlasticSurgeryHPecking
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Cheek Acupuncture in Vaginal Tightening Surgery
- ClinicalTrials.gov ID
- NCT06587711
- Acronym / sponsor ID
- PlasticSurgeryHPecking
- Conditions
- Pain Vulva
- Keywords
- Acupuncture, Analgesia, Vaginal tighting surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cheek acupuncture treatmnet | Experimental | Procedure: acupuncture treatmentPatients in the experimental group are treated with cheek acupuncture. |
| sham acupuncture treatment | Sham comparator | Procedure: acupuncture treatmentPatients in the control group are treated with sham acupuncture. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture treatmentPatients in experimental group received acupuncture at specific acupoint on the face, patients in control group received sham acupuncture at non-acupoint on the face. | Procedure or surgery | cheek acupuncture treatmnet, sham acupuncture treatment |
Primary outcome
Intraoperative opioid consumption
Time frame: End of surgery
Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption
17 secondary outcomes
Patient intravenous controlled analgesia (PCIA) pump consumption
Time frame: 24 hours after surgery
the rest numerical rating scale (NRS) scores
Time frame: 24 hours after surgery, 48 hours after surgery
the coughing numerical rating scale (NRS) scores
Time frame: 24 hours after surgery, 48 hours after surgery
15-item quality of recovery (QoR-15)
Time frame: 1 day after surgery, 2 day after surgery
Athens Insomnia Scale (AIS)
Time frame: 24 hours after surgery, 48 hours after surgery
Hospital Anxiety and Depression Scale（HADS）
Time frame: 24 hours after surgery, 48 hours after surgery
Patient satisfaction
Time frame: 48 hours after surgery
Systolic blood pressure (SBP)
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Diastolic blood pressure (DBP)
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Mean blood pressure (MBP)
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Heart rate (HR)
Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Opioid-related side effects
Time frame: 0~48 hours after surgery
Acupuncture-related side effects
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Dong, doctorate study chair
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture treatment in people with Pain Vulva, run by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Chunmei, doctorate (+8618611612186, chunmeichen2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative opioid consumption (time frame: End of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.