Auricular AcupressureNCT07277478
Effects of Auricular Acupressure on Relieving Pain in Postpartum Women With Episiotomy
A study testing auricular patch in people with Auricular Acupressure and Episiotomy Pain, run by HSIAO AI WEN at 1 site in Taiwan.
Trial summary
This randomized, single-blind controlled trial examined the effects of auricular acupressure on postpartum women who underwent episiotomy. A total of 86 participants were allocated to either an intervention group, which received routine care plus transparent auricular patches containing magnetic beads applied to… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Auricular Acupressure, Episiotomy Pain
- What is being tested?
- auricular patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Dec 2024to 12 Sep 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
-Inclusion Criteria-
- Women with singleton pregnancies who delivered vaginally.
- Women who underwent episiotomy.
- Gestational age between 37 and 42 weeks.
- Willing to participate in the study and provide signed informed consent.
- Age 18 years or older.
-Exclusion Criteria-
- Women with skin lesions or allergies at the auricular acupressure site.
- Women with gynecological disorders, such as uterine fibroids, adenomyosis, or endometriosis.
- Women or newborns with severe postpartum complications, such as postpartum hemorrhage, infection, perineal hematoma, major neonatal diseases, or admission to the neonatal intensive care unit.
- Women with psychiatric disorders, such as anxiety or depression.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized, single-blind controlled trial examined the effects of auricular acupressure on postpartum women who underwent episiotomy. A total of 86 participants were allocated to either an intervention group, which received routine care plus transparent auricular patches containing magnetic beads applied to selected acupoints, or a control group, which received identical patches without magnetic beads. The patches were applied for 48 hours after delivery. Perineal pain and its impact on daily activities were assessed at 2, 12, 24, and 48 hours postpartum, while satisfaction with perineal pain care was measured at 48 hours. Using independent t-tests, chi-square tests, and generalized estimating equations, the study evaluated whether auricular acupressure reduced perineal wound pain, lessened pain-related interference with daily activities, and improved satisfaction with perineal pain management.
- Conditions
- Auricular Acupressure, Episiotomy Pain
- Being tested
- auricular patch
- Keywords
- episiotomy, auricular acupressure, pain, impact on daily life, satisfaction with pain management
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular patchDevice
After placental delivery, the intervention group received routine care plus a transparent patented auricular patch containing magnetic beads, while the control group received a transparent patented auricular patch without magnetic beads. The selected acupoints included internal genitalia (TF2), external genitalia (HX4), Shenmen (TF4), sympathetic (AH6a), and subcortex (AT4)
| Study group | Role | What they receive |
|---|---|---|
| auricular patch containing magnetic beads | Experimental | After placental delivery, the intervention group received routine care plus a transparent patented auricular patch containing magnetic beads, while the control group received a transparent patented auricular patch without magnetic beads. The selected acupoints included internal genitalia (TF2), external genitalia (HX4), Shenmen (TF4), sympathetic (AH6a), and subcortex (AT4). Receives: Device: auricular patch |
| auricular patch without magnetic beads | Placebo comparator | After placental delivery, the intervention group received routine care plus a transparent patented auricular patch containing magnetic beads, while the control group received a transparent patented auricular patch without magnetic beads. The selected acupoints included internal genitalia (TF2), external genitalia (HX4), Shenmen (TF4), sympathetic (AH6a), and subcortex (AT4). Receives: Device: auricular patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
perineal pain
Structured questionnaires were used to assess perineal pain and its impact on daily activities at 2, 12, 24, and 48 hours postpartum.
Measured: At 2, 12, 24, and 48 hours postpartum
Secondary outcomes (2)
impact on daily life
Structured questionnaires were used to assess perineal pain and its impact on daily activities at 2, 12, 24, and 48 hours postpartum.
Measured: At 2, 12, 24, and 48 hours postpartum
satisfaction with pain management
At 48 hours postpartum, and satisfaction with perineal pain care at 48 hours
Measured: At 48 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start7 Dec 2024
- Primary completion10 Apr 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auricular AcupressureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants were postpartum women who had undergone episiotomy and were randomly assigned to the intervention or control group using an Excel-generated random allocation table. A total of 90 patients were enrolled, with 4 excluded, resulting in 43 participants in each group. Demographic data were collected before the intervention. After placental delivery, the intervention group received routine care plus a transparent patented auricular patch containing magnetic beads, while the control group received a transparent patented auricular patch without magnetic beads. The selected acupoints included internal genitalia (TF2), external genitalia (HX4), Shenmen (TF4), sympathetic (AH6a), and subcortex (AT4).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- HSIAO AI WEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HSIAO AI WEN, Fu Jen Catholic University Hospital
- Investigators
- AI WEN HSIAO, Study chair, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277478
- Sponsor's protocol ID
- FJUH113431
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auricular Acupressure on Relieving Pain in Postpartum Women With Episiotomy
- ClinicalTrials.gov ID
- NCT07277478
- Acronym / sponsor ID
- FJUH113431
- Conditions
- Auricular Acupressure, Episiotomy Pain
- Keywords
- episiotomy, auricular acupressure, pain, impact on daily life, satisfaction with pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- HSIAO AI WENUniversity, hospital or other
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 11 Dec 2025 (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.
This randomized, single-blind controlled trial examined the effects of auricular acupressure on postpartum women who underwent episiotomy. A total of 86 participants were allocated to either an intervention group, which received routine care plus transparent auricular patches containing magnetic beads applied to selected acupoints, or a control group, which received identical patches without magnetic beads. The patches were applied for 48 hours after delivery. Perineal pain and its impact on daily activities were assessed at 2, 12, 24, and 48 hours postpartum, while satisfaction with perineal pain care was measured at 48 hours. Using independent t-tests, chi-square tests, and generalized estimating equations, the study evaluated whether auricular acupressure reduced perineal wound pain, lessened pain-related interference with daily activities, and improved satisfaction with perineal pain management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- participants were postpartum women who had undergone episiotomy and were randomly assigned to the intervention or control group using an Excel-generated random allocation table. A total of 90 patients were enrolled, with 4 excluded, resulting in 43 participants in each group. Demographic data were collected before the intervention. After placental delivery, the intervention group received routine care plus a transparent patented auricular patch containing magnetic beads, while the control group received a transparent patented auricular patch without magnetic beads. The selected acupoints included internal genitalia (TF2), external genitalia (HX4), Shenmen (TF4), sympathetic (AH6a), and subcortex (AT4).
| Arm | Type | Receives |
|---|---|---|
| auricular patch containing magnetic beads | Experimental | Device: auricular patchAfter placental delivery, the intervention group received routine care plus a transparent patented auricular patch containing magnetic beads, while the control group received a transparent patented auricular patch without magnetic beads. The selected acupoints included internal genitalia (TF2), external genitalia (HX4), Shenmen (TF4), sympathetic (AH6a), and subcortex (AT4). |
| auricular patch without magnetic beads | Placebo comparator | Device: auricular patchAfter placental delivery, the intervention group received routine care plus a transparent patented auricular patch containing magnetic beads, while the control group received a transparent patented auricular patch without magnetic beads. The selected acupoints included internal genitalia (TF2), external genitalia (HX4), Shenmen (TF4), sympathetic (AH6a), and subcortex (AT4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 patchAfter placental delivery, the intervention group received routine care plus a transparent patented auricular patch containing magnetic beads, while the control group received a transparent patented auricular patch without magnetic beads. The selected acupoints included internal genitalia (TF2), external genitalia (HX4), Shenmen (TF4), sympathetic (AH6a), and subcortex (AT4) | Device | auricular patch containing magnetic beads, auricular patch without magnetic beads |
Primary outcome
perineal pain
Time frame: At 2, 12, 24, and 48 hours postpartum
Structured questionnaires were used to assess perineal pain and its impact on daily activities at 2, 12, 24, and 48 hours postpartum.
2 secondary outcomes
impact on daily life
Time frame: At 2, 12, 24, and 48 hours postpartum
satisfaction with pain management
Time frame: At 48 hours postpartum
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 11 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Auricular Acupressure
Not yet recruiting
Battlefield Acupressure for Acute Back Pain Management in the Emergency Department
Acute Back Pain
Not yet recruiting
Auricular Point Acupressure for Pain
HIV (Human Immunodeficiency Virus), Pain
Recruiting
Individualized TCM Pattern-Based Thread-Embedding Acupuncture Plus Auricular Acupressure for Chronic Insomnia
Insomnia, Nonorganic, Chronic Insomnia Disorder
Enrolling by invitation
Auricular Acupressure for Chronic Low Back Pain in Postmenopausal Women
Chronic Low Back Pain (Non-specific, Uncomplicated)
Recruiting
Electroacupuncture vs. Auricular Acupressure vs. Waitlist Control for Breast Cancer Endocrine Therapy-Related Joint Pain
Breast Cancer Survivors, Endocrine Therapy-Induced Joint Pain
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.
AI WEN HSIAO study chair
National Taipei University of Nursing and Health Sciences
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 patch in people with Auricular Acupressure and Episiotomy Pain, run by HSIAO AI WEN at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Dec 2025. 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 Taiwan. 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?
perineal pain (time frame: At 2, 12, 24, and 48 hours postpartum). 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 11 Dec 2025.