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

NCT06214663 | Unknown

• 1 other identifier: E2-20-11
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Labor Pain and to Reduce Pain

Keywords

Delivery; Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

0.9 NaCl solution OTHER

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

MeSH Terms

Conditions

Labor Pain; Pain; Agnosia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: January 20, 2024
• Primary Completion: April 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01