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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Labor Pain and to Reduce Pain
• Intervention / Treatment: Other: 0.9 NaCl solution

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria:

• Patients who do not volunteer to participate in the study will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigation of the analgesic effects of intradermal and subdermal sterile water injection on active labor pain.	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. he patient's (in active labor with 6 cm cervical dilatation) VAS score evaluation will be measured for labor pain and repeated.	10, 30, 60 and 90 minutes after injection

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Delivery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: E2-20-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No