The Effect of Sacral Massage and Sterile Water Injection During Childbirth on Pain Level and Birth Satisfaction

NCT07702773 | Active Not Recruiting

• 1 other identifier: 2025-10/03
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Childbirth is a physiological, psychological, and social process. Ineffective management of lower back pain during labor reduces oxygen supply to the fetus, increasing hypoxia, distress, perinatal morbidity, and mortality rates. Non-pharmacological approaches such as massage, breathing techniques, sterile water injection, aromatherapy, hydrotherapy, transcutaneous nerve stimulation, and acupressure are used to reduce pain during childbirth. Sterile Water Injection (SSI) is one of the non-pharmacological methods applied to reduce lower back pain during childbirth. Injecting sterile water into the skin acts as a pain stimulant that alters pain perception in women experiencing severe back and lower back pain during labor. SSI is considered an attractive and current method for reducing lower back pain during childbirth due to its lack of side effects and risk to the fetus. Sacral massage, on the other hand, is applied to pregnant women, usually in the form of back or sacral massage, to reduce pain perception and increase comfort during childbirth. The mechanism of action of both Sterile Water Injection and sacral massage applied to the sacral region is the same and bypasses the gate mechanisms expressed by gate control theory. It prevents the pain-causing agent from passing through the "door," thus preventing the pain stimulus from reaching consciousness. Sacral massage and sterile water injection applied during labor stimulate the central nervous system, causing a number of hormonal changes. Furthermore, the central nervous system stimulates oxytocin release, leading to mental detachment from pain and reduced anxiety. Therefore, women giving birth can tolerate pain better. Birth satisfaction is crucial for maintaining maternal and infant health. The provision of quality healthcare services is directly proportional to a positive birth experience and maternal satisfaction. Since sterile water injection and sacral massage are low-cost interventions with no side effects for the mother and fetus, they can be easily applied to alleviate labor pain among women giving birth. The literature shows a limited number of studies comparing sterile water injection and sacral massage in the sacral region during labor. This study will be conducted to determine the effect of sterile water injection and sacral massage applied to the sacral region on labor pain and satisfaction in pregnant women.

Conditions

Pain Alleviation; Birth

Keywords

Sterile Water Injection; Sacral massage

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS) score for labor pain

  The VAS is a 10-cm horizontal line leadership tool used to measure pain intensity. Scores range from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more severe pain.

  During labor at 6 cm, and 10 cm of cervical dilations.

Study Arms (3)

Sterile Water Injection group1

EXPERIMENTAL

Sterile water is a pain stimulant that alters pain perception in women experiencing severe back and pelvic pain during childbirth, when injected into the skin.

Procedure: Sterile Water Injection

Sacral massage group 2

EXPERIMENTAL

Sacral massage is applied to pregnant women, usually in the form of back or sacral massage, to the sacral region to reduce pain perception and increase comfort during childbirth.

Procedure: sacral press

control group

NO INTERVENTION

Interventions

Sterile Water Injection PROCEDURE

Intradermal or subcutaneous sterile water injection administered to the lumbar/sacral region to relieve severe back pain during labor.

Sterile Water Injection group1

sacral press PROCEDURE

Continuous manual pressure applied to the sacral area during labor contractions to alleviate back pain.

Sacral massage group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 19 years and older
• being in the gestational week,
• Having a singleton pregnancy,
• Being nulliparous,
• Dilation of 6 cm or more (as it meets the active labor criterion),
• Having regular contractions,
• Not receiving oxytocin induction (for experimental groups),
• Absence of bleeding diathesis and pathology in coagulation tests,
• Fetus in vertex position,
• No history of EMR (Early Rupture of Membranes),
• Absence of a chronic disease,
• Absence of communication and perception problems,
• Voluntary participation in the study

You may not qualify if:

• Experiencing any complications during delivery,
• Having a history of using analgesic drugs to accelerate delivery

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Numune Hospital

Sivas, Sivas, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 14, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)