Subcutaneous Sterile Water Injection for Relief of Low Back Pain
Keywords
Abstract
Description
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:
1. Personal data questionnaire
2. Visual Analogue Scale and Face analogue scale
3. Satisfaction scale
Dates
| Last Verified: | 05/31/2016 |
| First Submitted: | 06/17/2016 |
| Estimated Enrollment Submitted: | 06/20/2016 |
| First Posted: | 06/26/2016 |
| Last Update Submitted: | 06/20/2016 |
| Last Update Posted: | 06/26/2016 |
| Actual Study Start Date: | 01/31/2015 |
| Estimated Primary Completion Date: | 05/31/2016 |
| Estimated Study Completion Date: | 05/31/2016 |
Condition or disease
Intervention/treatment
Other: Subcutaneous sterile water injection
Other: saline injection
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Sterile Water injection Subcutenous injection at low back portion during labor pain | |
| Experimental: saline injection Subcutenous injection at low back portion during labor pain |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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) |
Outcome
Primary Outcome Measures
1. Pain relief [two hours for each client]
2. Women's Saisfaction [each 15 min until 120 min]
