Subcutaneous Sterile Water Injection for Relief of Low Back Pain

Study Overview
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Brief Summary
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To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth

Detailed Description
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Study sample: The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection) Setting: Labor ward in Women's health center at Assiut university hospital Study design: Experimental Randomized control study Sample size: The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria In labour (spontaneous or induced During first stageof labour Primary and multiparous women A term singleton pregnancy (between 37 + 0 and 41 weeks) Have a fetus in a cephalic presentation Experience back pain assessed by visual analogue scale VAS and Face pain analogue ( Warden V, Hurley AC, Volicer L.2003) Provide informed consent. Exclusion criteria Multiple pregnancy Malpresentation (breech, transverse, shoulder) Previous CS Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia. Study Tools: Personal data questionnaire Visual Analogue Scale and Face analogue scale Satisfaction scale

Official Title
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Subcutaneous Sterile Water Injection for Relief of Low Back Pain During Normal Labor: Randomized Controlled Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Subcutaneous sterile water injection
* Other: saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In labour (spontaneous or induced record During first stage of labour Primary and multiparous women A term singleton pregnancy (between 37 + 0 and 41 weeks) Have a fetus in a cephalic presentation Experience back pain assessed by visual analogue scale VAS and Face pain analogue Provide informed consent. Exclusion Criteria: Women with chronic disease Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc) Complicated labor process ( obstructed, preterm labor, twins)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sterile Water injection<br>Subcutenous injection at low back portion during labor pain | Other: Subcutaneous sterile water injection<br>* sterile water injection in two points of low back pain<br>* Other names: sterile water injection;Other: saline injection<br>* Saline injection in two points of low back pain<br>* Other names: Natural pain relief;|
| Experimental: saline injection<br>Subcutenous injection at low back portion during labor pain | Other: Subcutaneous sterile water injection<br>* sterile water injection in two points of low back pain<br>* Other names: sterile water injection;Other: saline injection<br>* Saline injection in two points of low back pain<br>* Other names: Natural pain relief;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | the investigator spend two hours with each client to measure the effect of pain relief | two hours for each client | 
| Women's Saisfaction | measuring pain relief within different minutes | each 15 min until 120 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women, severe, low back ache, labor