Subcutaneous Sterile Water Injection for Relief of Low Back Pain

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2016

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

Interventions

  • Other: Subcutaneous sterile water injection
    • sterile water injection in two points of low back pain
  • Other: saline injection
    • Saline injection in two points of low back pain

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Woman’s Health University Hospital, Egypt
  • Provider of Information About this Clinical Study
    • Principal Investigator: Howieda Fouly, PhD, Lecturer of Obstetric & gynecological nursing – Woman’s Health University Hospital, Egypt

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