Clinical trial NCT06407505: The Effect of LI4 Acupressure on Perineal Pain and Postpartum Comfort During Episiotomy Repair
Official title: The Effect of LI4 Acupressure on Perineal Pain and Postpartum Comfort During Episiotomy Repair
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Labor Pain
Perineal Pain
Postpartum Comfort
Keywords: Acupressure, LI4 acupoint, Perineal pain, Postpartum comfort
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Our study was designed as a randomized, controlled, single-blind, placebo-designed experimental study.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 7 item perineal pain intensity measure
timeFrame: 3 hours
measure: Postpartum perineal pain intensity measure
timeFrame: 30 minutes
Secondary outcomes:
measure: Postpartum comfort level
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: TC Uskudar University
name: Derya Deniz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Ozlem Can Gurkan
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.