The Effect of LI4 Acupressure on Perineal Pain and Postpartum Comfort During Episiotomy Repair

NCT06407505 | Not Yet Recruiting

• 1 other identifier: 01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study was planned to evaluate the effect of LI4 acupressure application on perineal pain and postpartum comfort during episiotomy repair. Our study was designed as a randomized, controlled, single-blind and placebo design experimental study. The study is planned to be conducted in the maternity ward of Istanbul SBU Kanuni Sultan Süleyman Training and Research Hospital between May 1, 2024 and October 20, 2025. The sample of the study will consist of a total of 90 pregnant women who were hospitalized in the maternity ward and agreed to participate in the study. During the episiotomy repair, the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 seconds in succession and a 10-second break will be taken. A different point 1-1.5 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be pressed. No intervention will be applied to the control group.

Conditions

Labor Pain; Perineal Pain; Postpartum Comfort

Keywords

Acupressure, LI4 acupoint, Perineal pain, Postpartum comfort

Outcome Measures

Primary Outcomes (2)

• 7 item perineal pain intensity measure

  Self-reported pain intensity before starting the first suturing, at the end of the 5th application, at the end of the 10th application, immediately after suturing was completed, and at 30 min, 60 min and 120 min after suturing was completed. Each item will be obtained using a visual analog scale. Each item is scored 0-10 (0=no pain; 10=unbearable pain).

  3 hours

• Postpartum perineal pain intensity measure

  Pain intensity will be determined 120 minutes after completion of stitching using the McGill scale form.There are 3 sections in the form. The first section consists of 15 descriptive words, 11 of which measure the sensory and 4 of which measure the perceptual dimension of pain. The words in the first section were rated on an intensity scale from 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Very). Three pain scores are obtained from this section: sensory pain score, perceptual pain score and total pain score. In the second section, the pain intensity of the person is measured with 5 word groups ranging from "mild pain" to "unbearable pain". In the third section, the current pain intensity of the patient is measured with a visual comparison scale.

  30 minutes

Secondary Outcomes (1)

• Postpartum comfort level

  30 minutes

Study Arms (3)

Acupressure group

EXPERIMENTAL

During the episiotomy repair, the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 s in succession, followed by a 10 s break.

Other: Acupressure group

Placebo Group

PLACEBO COMPARATOR

A different point 1-1.5 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be compressed.

Other: Placebo group

Control Group

NO INTERVENTION

Group receiving routine care.

Interventions

Acupressure group OTHER

LI4 acupressure applied group.

Also known as: LI4 acupressure group, experimental

Acupressure group

Placebo group OTHER

Group where acupressure was applied to an area 1.5 cm away at the LI4 acupressure point

Placebo Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Speaks Turkish,
• weeks gestation and in vaginal labor,
• The one with a single fetus and vertex development,
• Fetal weight between 2000-4000 gr,
• To have performed with mediolateral episiotomy,
• Pregnant women admitted to the delivery room,

You may not qualify if:

• Vacuum applied
• Forceps delivery
• Vaginal tear/ Disurge
• Anal sphincter damage
• Unusual need for lidocaine during episiotomy repair (more than 10ml)
• Intact perineum
• Any postnatal complications in the newborn.

Sponsors & Collaborators

• Uskudar University: lead

Related Publications (2)

• Solt Kirca A, Guducu N, Ikiz B. The Effect of Virtual Glasses Application on Pain and Anxiety During Episiotomy Repair: Randomized Controlled Trial. Pain Manag Nurs. 2023 Oct;24(5):e123-e130. doi: 10.1016/j.pmn.2023.06.004. Epub 2023 Jul 16.

  PMID: 37455184 RESULT

• Orhan M, Bulez A. The Effect of Virtual Reality Glasses Applied During the Episiotomy On Pain and Satisfaction: A Single Blind Randomized Controlled Study. J Pain Res. 2023 Jun 29;16:2227-2239. doi: 10.2147/JPR.S412883. eCollection 2023.

  PMID: 37404226 RESULT

Related Links

• The Effect of Virtual Glasses Application on Pain and Anxiety During Episiotomy Repair: Randomized Controlled Trial
• The Effect of Virtual Reality Glasses Applied During the Episiotomy On Pain and Satisfaction: A Single Blind Randomized Controlled Study

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Derya Deniz, PhD

  TC Uskudar University

  PRINCIPAL INVESTIGATOR

• Ozlem Can Gurkan

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Derya Deniz, PhD

CONTACT

+90537312147; derya.deniz@uskudar.edu.tr

Ozlem Can Gurkan

CONTACT

+905325963373; ozlemcangurkan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The process will not know the group to which the patient belongs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Our study was designed as a randomized, controlled, single-blind, placebo-designed experimental study.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: June 1, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share