Pain PostoperativeAA-CSNCT07322601
Supportive Analgesic Effect of Auricular Acupressure (AA) After Cesarean Section (CS)
A study testing Auricular Acupressure in people with Pain Postoperative and Caesarean Section; Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Introduction: Severe acute pain after cesarean section is an independent risk factor for the development of chronic pain and increases the risk of postpartum depression threefold. Pain also reduces the mother's ability to breastfeed and care for her child. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pain Postoperative, Caesarean Section; Pain
- What is being tested?
- Auricular Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Oct 2024to 30 Jun 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years of age
- Gestational age ≥ 37 weeks
- Alert and cooperative with the treating physicians
- Able to understand and use the Visual Analog Scale (VAS)
- Preoperative American Society of Anesthesiologists (ASA) Physical Status Classification System I-II
- Anesthesia: spinal anesthesia;
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- Pfannenstiel suprapubic transverse incision
- Infant 5-minute Appearance, Pulse, Grimace, Activity, Respiration score (Apgar score) > 7
- Cesarean operative time ≤ 60 minutes
- Singleton pregnancy
- Voluntary agreement to participate.
Who cannot join
- Contraindication to diclofenac
- Surgical complications, including hysterectomy and postpartum hemorrhage (> 1000 ml)
- History of acupuncture syncope
- Preoperative chronic pain and/or regular preoperative use of analgesics
- Addiction to or dependence on opioids or alcohol
- Diabetes mellitus or HIV infection
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- Prior Auricular acupressure
- Skin lesions of the auricle
- Surgical wound infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Supportive Analgesic Effect of Auricular Acupressure After Cesarean Section: A Randomized Clinical Controlled Trial
Introduction:
Severe acute pain after cesarean section is an independent risk factor for the development of chronic pain and increases the risk of postpartum depression threefold. Pain also reduces the mother's ability to breastfeed and care for her child. This study aimed to evaluate the supportive effectiveness of auricular acupressure in reducing incision pain and uterine contraction pain in women undergoing cesarean section, compared with sham auricular acupressure.
Read more
Methods:
A randomized, controlled, single-blind clinical trial was conducted in seventy women undergoing cesarean section, randomly allocated (1:1) to an auricular acupressure or sham group. The study group received vaccaria seeds, and the sham group received non-vaccaria patches on both ears. Both groups were treated at the Shenmen, Lung, Internal Genitalia, Pelvis, Subcortex, and Sympathetic points. Pain was assessed using the Visual Analog Scale (VAS), and diclofenac consumption was recorded over the first 48 hours postpartum.
Read the detailed description
Participants are instructed to apply pressure to the patches three times daily (morning, noon, and evening). Supplemental acupressure is also performed whenever the participant feels pain, with the goal of achieving the 'De-qi' sensation (a feeling of soreness or tingling). All patches are maintained for 48 hours. Postoperative analgesia follows a standardized hospital protocol, with diclofenac administered as rescue medication.
Safety monitoring is strictly implemented throughout the study. If participants experience symptoms such as headache, dizziness, or syncope following the application of auricular patches, they will be managed according to standardized acupuncture safety protocols. Participants will be withdrawn from the study if they develop adverse reactions, including local allergic reactions at the patch site, persistent local pain, or severe dizziness.
- Conditions
- Pain Postoperative, Caesarean Section; Pain
- Being tested
- Auricular Acupressure, Sham Auricular Acupressure Group
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupressureOther
Also called Auricular Acupuncture, Acupuncture
In the Auricular Acupressure group, participants received auricular acupressure using vaccaria seeds applied to the following points on both ears: Ear Shenmen (TF4), Lung (CO14), Internal Genitalia (TF2), Pelvis (TF5), Subcortex (AT4), and Sympathetic (AH6), in addition to standard postoperative care.
Each participant received a single treatment session within 5 hours after cesarean section, once transferred to the Obstetrics Department. Seeds were retained for 2 days. All acupuncture procedures were performed by licensed traditional medicine physicians who had been trained and standardized before the study.
Sham Auricular Acupressure GroupOther
Also called Sham Acupuncture, Sham Auricular Acupuncture
In the Sham Auricular Acupressure Group, participants received adhesive patches without seeds, identical in size and appearance to the Auricular Acupressure Group patches, applied to the same auricular points. Both groups received standard postoperative care.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupressure Group | Experimental | Participants received auricular acupressure using Vaccaria seeds applied to Shenmen [Antitragus-4 (TF4)], Lung [Concha-14 (CO14)], Internal Genitalia [Triangular fossa-2 (TF2)], Pelvis [Triangular fossa-5 (TF5)], Subcortex [Antitragus-4 (AT4)], and Sympathetic [Antihelix-6 (AH6)]. Receives: Other: Auricular Acupressure |
| Sham Auricular Acupressure Group | Sham comparator | Participants received identical adhesive patches without seeds applied to the same auricular points. Receives: Other: Sham Auricular Acupressure Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section.
Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section. The Visual Analog Scale (VAS) consists of a line where respondents are asked to mark their level of pain. The left-most point (zero) represents no pain and the right-most point (10) represents extreme pain. The higher the score, the more severe the pain.
Measured: 12, 24, 48 hours postoperative
VAS scores for pain intensity at rest, pain intensity on movement, and uterine contraction pain
Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section. The Visual Analog Scale (VAS) consists of a line where respondents are asked to mark their level of pain. The left-most point (0) represents 'no pain,' while the right-most point (10) represents 'extreme pain.' The higher the score, the more severe the pain.
Measured: From enrollment to the end of treatment at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start14 Oct 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to the auricular acupressure group or sham auricular acupressure group in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lê Phương Linh, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Ly, PhD, Study chair, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322601
- Sponsor's protocol ID
- 3962/DHYD-HDDD
- Acronym
- AA-CS
- Status last verified
- Oct 2025
- First submitted
- 14 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The type of data set or supporting information being shared. Options include: study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Supportive Analgesic Effect of Auricular Acupressure After Cesarean Section: A Randomized Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT07322601
- Acronym / sponsor ID
- AA-CS / 3962/DHYD-HDDD
- Conditions
- Pain Postoperative, Caesarean Section; Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Jan 2026 (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.
Introduction:
Severe acute pain after cesarean section is an independent risk factor for the development of chronic pain and increases the risk of postpartum depression threefold. Pain also reduces the mother's ability to breastfeed and care for her child. This study aimed to evaluate the supportive effectiveness of auricular acupressure in reducing incision pain and uterine contraction pain in women undergoing cesarean section, compared with sham auricular acupressure.
Methods:
A randomized, controlled, single-blind clinical trial was conducted in seventy women undergoing cesarean section, randomly allocated (1:1) to an auricular acupressure or sham group. The study group received vaccaria seeds, and the sham group received non-vaccaria patches on both ears. Both groups were treated at the Shenmen, Lung, Internal Genitalia, Pelvis, Subcortex, and Sympathetic points. Pain was assessed using the Visual Analog Scale (VAS), and diclofenac consumption was recorded over the first 48 hours postpartum.
Detailed description
Participants are instructed to apply pressure to the patches three times daily (morning, noon, and evening). Supplemental acupressure is also performed whenever the participant feels pain, with the goal of achieving the 'De-qi' sensation (a feeling of soreness or tingling). All patches are maintained for 48 hours. Postoperative analgesia follows a standardized hospital protocol, with diclofenac administered as rescue medication.
Safety monitoring is strictly implemented throughout the study. If participants experience symptoms such as headache, dizziness, or syncope following the application of auricular patches, they will be managed according to standardized acupuncture safety protocols. Participants will be withdrawn from the study if they develop adverse reactions, including local allergic reactions at the patch site, persistent local pain, or severe dizziness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to the auricular acupressure group or sham auricular acupressure group in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupressure Group | Experimental | Other: Auricular AcupressureParticipants received auricular acupressure using Vaccaria seeds applied to Shenmen [Antitragus-4 (TF4)], Lung [Concha-14 (CO14)], Internal Genitalia [Triangular fossa-2 (TF2)], Pelvis [Triangular fossa-5 (TF5)], Subcortex [Antitragus-4 (AT4)], and Sympathetic [Antihelix-6 (AH6)]. |
| Sham Auricular Acupressure Group | Sham comparator | Other: Sham Auricular Acupressure GroupParticipants received identical adhesive patches without seeds applied to the same auricular points. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18-40 years of age
- Gestational age ≥ 37 weeks
- Alert and cooperative with the treating physicians
- Able to understand and use the Visual Analog Scale (VAS)
- Preoperative American Society of Anesthesiologists (ASA) Physical Status Classification System I-II
Key exclusion criteria (9 listed)
- Contraindication to diclofenac
- Surgical complications, including hysterectomy and postpartum hemorrhage (> 1000 ml)
- History of acupuncture syncope
- Preoperative chronic pain and/or regular preoperative use of analgesics
- Addiction to or dependence on opioids or alcohol
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 |
|---|---|---|
| Auricular AcupressureAlso: Auricular Acupuncture, AcupunctureIn the Auricular Acupressure group, participants received auricular acupressure using vaccaria seeds applied to the following points on both ears: Ear Shenmen (TF4), Lung (CO14), Internal Genitalia (TF2), Pelvis (TF5), Subcortex (AT4), and Sympathetic (AH6), in addition to standard postoperative care. Each participant received a single treatment session within 5 hours after cesarean section, once transferred to the Obstetrics Department. Seeds were retained for 2 days. All acupuncture procedures were performed by licensed traditional medicine physicians who had been trained and standardized before the study. | Other | Auricular Acupressure Group |
| Sham Auricular Acupressure GroupAlso: Sham Acupuncture, Sham Auricular AcupunctureIn the Sham Auricular Acupressure Group, participants received adhesive patches without seeds, identical in size and appearance to the Auricular Acupressure Group patches, applied to the same auricular points. Both groups received standard postoperative care. | Other | Sham Auricular Acupressure Group |
Primary outcome
Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section.
Time frame: 12, 24, 48 hours postoperative
Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section. The Visual Analog Scale (VAS) consists of a line where respondents are asked to mark their level of pain. The left-most point (zero) represents no pain and the right-most point (10) represents extreme pain. The higher the score, the more severe the pain.
VAS scores for pain intensity at rest, pain intensity on movement, and uterine contraction pain
Time frame: From enrollment to the end of treatment at 48 hours
Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section. The Visual Analog Scale (VAS) consists of a line where respondents are asked to mark their level of pain. The left-most point (0) represents 'no pain,' while the right-most point (10) represents 'extreme pain.' The higher the score, the more severe the pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Yes. The type of data set or supporting information being shared. Options include: study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code.
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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.
Ly, PhD study chair
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupressure in people with Pain Postoperative and Caesarean Section; Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jan 2026. 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section. (time frame: 12, 24, 48 hours postoperative). The study lists 2 primary outcomes in all. 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 7 Jan 2026.