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

NCT ID: NCT06407505

Last Updated: 2024-05-09

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-10-20

Brief Summary

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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.

Detailed Description

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Background: Pain relief in the intrapartum period is important for maternal-fetal health. Studies in the literature have generally focused on the first stage of labor. When the labor process is considered as a whole, women may also experience pain during episiotomy repair. In recent years, traditional methods have become more preferred due to the side effects of pharmacologic treatments to relieve pain symptoms. Acupressure, one of the traditional methods, is used to relieve pain and various symptoms by applying pressure on acupuncture points with manual techniques. In the literature, LI4 acupressure is applied to relieve pain symptoms caused by various reasons. However, among the studies reviewed, no study was found to investigate the effect of LI4 acupressure application on perineal pain perceived during episiotomy repair and postpartum comfort level.

Objective: The study was planned to evaluate the effect of LI4 acupressure on perineal pain and postpartum comfort during episiotomy repair.

Materials and Methods: Our study was designed as a randomized, controlled, single-blind, placebo-designed experimental study. The study will be conducted in the maternity ward of Istanbul SBÜ 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 (experimental group= 30, control group= 30, placebo group= 30) 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 s in succession, followed by a 10 s break. The procedure will start with the first suturing. Vital signs will be taken just before the first suturing and after the suturing is completed. 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. No intervention will be applied to the control group. Data will be obtained using the Pregnancy Identification Form, Visual Comparison Scale, Postpartum Comfort Scale, Labor Monitoring Form and McGill Pain Scale Short Form. The data obtained from the study will be analyzed in SPSS 23 statistical program in computer environment. In the evaluation of the data, mean, standard deviation, minimum and maximum values, frequency and percentage calculations, t-test and chi-square test will be used.

Conditions

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Labor Pain Perineal Pain Postpartum Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Our study was designed as a randomized, controlled, single-blind, placebo-designed experimental study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The process will not know the group to which the patient belongs.

Study Groups

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Acupressure group

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.

Group Type EXPERIMENTAL

Acupressure group

Intervention Type OTHER

LI4 acupressure applied group.

Placebo Group

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.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type OTHER

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

Control Group

Group receiving routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupressure group

LI4 acupressure applied group.

Intervention Type OTHER

Placebo group

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

Intervention Type OTHER

Other Intervention Names

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LI4 acupressure group experimental

Eligibility Criteria

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Inclusion Criteria

* Speaks Turkish,
* 37-42 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,

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Derya Deniz

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derya Deniz, PhD

Role: PRINCIPAL_INVESTIGATOR

TC Uskudar University

Ozlem Can Gurkan

Role: STUDY_DIRECTOR

Marmara University

Central Contacts

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Derya Deniz, PhD

Role: CONTACT

+90537312147

Ozlem Can Gurkan

Role: CONTACT

+905325963373

References

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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.

Reference Type RESULT
PMID: 37455184 (View on PubMed)

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.

Reference Type RESULT
PMID: 37404226 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/37455184/

The Effect of Virtual Glasses Application on Pain and Anxiety During Episiotomy Repair: Randomized Controlled Trial

https://pubmed.ncbi.nlm.nih.gov/37404226/

The Effect of Virtual Reality Glasses Applied During the Episiotomy On Pain and Satisfaction: A Single Blind Randomized Controlled Study

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id

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