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临床试验/NCT07702773
NCT07702773进行中(未招募)不适用

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

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2026年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
104
试验地点
1
主要终点
Visual analog scale (VAS) score for labor pain

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Sterile Water Injection (Procedure)

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.

干预措施: sacral press (Procedure)

control group

No Intervention

结局指标

主要结局

Visual analog scale (VAS) score for labor pain

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Guveri

Doctor

Sivas Numune Hospital

研究点 (1)

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