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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06214663
Enrollment
30
Registered
2024-01-19
Start date
2024-01-20
Completion date
2024-08-30
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain and to Reduce Pain

Keywords

Delivery, Pain, Analgesia

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.

Interventions

OTHER0.9 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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Investigation of the analgesic effects of intradermal and subdermal sterile water injection on active labor pain.10, 30, 60 and 90 minutes after injectionThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026