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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-07

Study Completion Date

2025-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Auricular Acupressure Episiotomy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

This study design was a randomized controlled single-blind trial.

Study Groups

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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).

Group Type EXPERIMENTAL

auricular patch

Intervention Type 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 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).

Group Type PLACEBO_COMPARATOR

auricular patch

Intervention Type 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)

Interventions

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auricular patch

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)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Women with singleton pregnancies who delivered vaginally.
2. Women who underwent episiotomy.
3. Gestational age between 37 and 42 weeks.
4. Willing to participate in the study and provide signed informed consent.
5. Age 18 years or older.

Exclusion Criteria

1. Women with skin lesions or allergies at the auricular acupressure site.
2. Women with gynecological disorders, such as uterine fibroids, adenomyosis, or endometriosis.
3. 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.
4. Women with psychiatric disorders, such as anxiety or depression.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes