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NCT Number: NCT07702773

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

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Numune Hospital

Sivas, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being 19 years and older
  • 38-42. 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

Exclusion criteria

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

Treatment and study plan

Sterile Water Injection

Procedure

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

sacral press

Procedure

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

Primary outcomes

  1. Visual analog scale (VAS) score for labor pain

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

    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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Acronym: Satisfaction

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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