Investigation of the Analgesic Effects of Intradermal and Subdermal Sterile Water Injection on Active Labor Pain

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-20

Study Completion Date

2024-08-30

Brief Summary

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Labour pain has different locations, intensity, quality and meaning for each woman, and the experience of pain changes throughout the delivery process. This pain is often associated with varying degrees of fetal malposition, particularly occipito-posterior position, which may apply pressure on pain-sensitive structures within the pelvis. Administration of Injections into the sacral area (both posterior iliac spines and 2 cm downward and medial) is used and have been shown to relieve the pain of labor. Controlling pain with simple methods can reduce the desire of mothers to give birth by cesarean section and make them more diligent for normal birth.

The benefit we expect from the research; Since sterile water injection is a safe, effective and low-cost method, it is important to understand the effectiveness of its use to reduce labor pain. It also aims to increase the knowledge of gynecologists about this method.

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Detailed Description

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Conditions

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Labor Pain and to Reduce Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Patients in active labor (6 cm cervical dilatation) will be randomly divided into 3 groups. For each patient, first, VAS score (visual analogue scale: patients were asked to evaluate their own pain on a vertical, unnumbered scale. Then, the patient's evaluation was graded with the help of a scale divided into 1/10 sections of the same length as the scale: "0: no pain and 10: "unbearable pain") will be measured for labor pain and repeated at 10, 30, 60 and 90 minutes after injection. Injections will be administered over the sacral area (both posterior iliac spines and 2 cm downward and medial), and this technique was described by Lytzen et al in 1989 and later standardized. The results will be compared between the three groups.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Interventions

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0.9 NaCl solution

Saline injections will be administered over the sacral area (both posterior iliac spines and 2 cm downward and medial), and this technique was described by Lytzen et al in 1989 and later standardized. The results will be compared between the three groups.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Singleton pregnant women with cephalic presentation who are admitted to the delivery room clinic for delivery, who do not have an additional chronic disease, who have not given birth before, and who are in the second stage of labor (active cervical dilatation of 6 cm and above) will be included in the study.