Subcutaneous Sterile Water Injection for Relief of Low Back Pain

Phase 1

• Conditions: Low Back Pain
• Interventions: Other: Subcutaneous sterile water injection; Other: saline injection

• Registration Number: NCT02813330
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

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

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

Study Timeline

• Study Start: 2015-02
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-18
• Study First Submitted QC: 2016-06-21
• Last Update Submitted: 2016-06-21
• Study First Posted: 2016-06-27
• Last Update Posted: 2016-06-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 336

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sterile Water injection	saline injection	Subcutenous injection at low back portion during labor pain
Sterile Water injection	Subcutaneous sterile water injection	Subcutenous injection at low back portion during labor pain
saline injection	Subcutaneous sterile water injection	Subcutenous injection at low back portion during labor pain
saline injection	saline injection	Subcutenous injection at low back portion during labor pain

Primary Outcome Measures

Name	Time	Method
Women's Saisfaction	each 15 min until 120 min	measuring pain relief within different minutes
Pain relief	two hours for each client	the investigator spend two hours with each client to measure the effect of pain relief