- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277478
Effects of Auricular Acupressure on Relieving Pain in Postpartum Women With Episiotomy
November 30, 2025 updated by: HSIAO AI WEN
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sanchong
-
Taipei, Sanchong, Taiwan, 241
- Hsiao Ai Wen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
-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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: auricular patch containing magnetic beads
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).
|
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)
|
|
Placebo Comparator: auricular patch without magnetic beads
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).
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At 2, 12, 24, and 48 hours postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
impact on daily life
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.
|
At 2, 12, 24, and 48 hours postpartum
|
|
satisfaction with pain management
Time Frame: At 48 hours postpartum
|
At 48 hours postpartum, and satisfaction with perineal pain care at 48 hours
|
At 48 hours postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: AI WEN HSIAO, National Taipei University of Nursing and Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2024
Primary Completion (Actual)
April 10, 2025
Study Completion (Actual)
September 12, 2025
Study Registration Dates
First Submitted
November 30, 2025
First Submitted That Met QC Criteria
November 30, 2025
First Posted (Actual)
December 11, 2025
Study Record Updates
Last Update Posted (Actual)
December 11, 2025
Last Update Submitted That Met QC Criteria
November 30, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJUH113431
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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