Effects of Auricular Acupressure on Relieving Pain in Postpartum Women With Episiotomy

NCT07277478 | Completed

• 1 other identifier: FJUH113431
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

episiotomy; auricular acupressure; pain; impact on daily life; satisfaction with pain management

Outcome Measures

Primary Outcomes (1)

• perineal pain

  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 Outcomes (2)

• impact on daily life

  At 2, 12, 24, and 48 hours postpartum

• satisfaction with pain management

  At 48 hours postpartum

Study Arms (2)

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).

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).

Device: auricular patch

Interventions

auricular patch DEVICE

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)

auricular patch containing magnetic beads; auricular patch without magnetic beads

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HSIAO AI WEN: lead

Study Sites (1)

Hsiao Ai Wen

Taipei, Sanchong, 241, Taiwan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• AI WEN HSIAO

  National Taipei University of Nursing and Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study design was a randomized controlled single-blind trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Model Details: 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).

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: December 7, 2024
• Primary Completion: April 10, 2025
• Study Completion: September 12, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)