Sterile Water Injections For Pain Relief İn Labor

Study Overview
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Brief Summary
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ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases. Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.

Official Title
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Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial

Conditions
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Labour Pain, Back Pain

Intervention / Treatment
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* Other: Sterile Water
* Other: Dry Injections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18-35 37-42 weeks of gestation Expecting vaginal delivery Cephalic presentation Single, healthy fetus Spontaneous onset of labor Active phase of first stage of labor (3-7 cm cervical dilatation) Severe low back pain (VAS>7cm) Required pain relief Exclusion Criteria: Gestation <37 weeks Multiple pregnancy Malpresentation Second stage labour Pharmacological analgesia prior to SWI Back pain assessed by VAS <7 Women whose labour would be considered high risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sterile Water Injection<br>Participants randomised to the intervention group received 4 intracutaneous injections of 0.1 ml sterile water into the skin surrounding the Michaelis rhomboid over the sacral area. | Other: Sterile Water<br>* 0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.<br>|
| Placebo Comparator: Dry Injection<br>Participants in the control group received 4 dry injections in the same region using an insulin needle . | Other: Dry Injections<br>* dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores-30 | In pain scoring Visual Analog Scale was used | at 30 mins after interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores-10 | In pain scoring Visual Analog Scale was used | at 10 mins after interventions | 
| Pain scores-60 | In pain scoring Visual Analog Scale was used | at 60 mins after interventions | 
| Pain scores-90 | In pain scoring Visual Analog Scale was used | at 90 mins after interventions | 
| Pain scores-120 | In pain scoring Visual Analog Scale was used | at 120 mins after interventions | 
| Pain scores-180 | In pain scoring Visual Analog Scale was used | at 180 mins after interventions | 
| APGAR score of neonate |  | at 5 mins after birth | 
| Maternal satisfaction | Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others | at 1 hour after birth | 
| Rates of breastfeeding-1 | In breastfeed scoring The Infant Breastfeeding Assessment Tool was used | at 1 hour after birth | 
| Rates of breastfeeding-24 | In breastfeed scoring The Infant Breastfeeding Assessment Tool was used | at 24.hours after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sterile Water Injection, Midwifery