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Subcutaneous Sterile Water Injection for Relief of Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Subcutaneous sterile water injection
saline injection
Sponsored by
Woman's Health University Hospital, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain focused on measuring Women, severe, low back ache, labor

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sterile Water injection

    saline injection

    Arm Description

    Subcutenous injection at low back portion during labor pain

    Subcutenous injection at low back portion during labor pain

    Outcomes

    Primary Outcome Measures

    Pain relief
    the investigator spend two hours with each client to measure the effect of pain relief
    Women's Saisfaction
    measuring pain relief within different minutes

    Secondary Outcome Measures

    Full Information

    First Posted
    June 18, 2016
    Last Updated
    June 21, 2016
    Sponsor
    Woman's Health University Hospital, Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02813330
    Brief Title
    Subcutaneous Sterile Water Injection for Relief of Low Back Pain
    Official Title
    Subcutaneous Sterile Water Injection for Relief of Low Back Pain During Normal Labor: Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    June 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Woman's Health University Hospital, Egypt

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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: Personal data questionnaire Visual Analogue Scale and Face analogue scale Satisfaction scale

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    Women, severe, low back ache, labor

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    336 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sterile Water injection
    Arm Type
    Experimental
    Arm Description
    Subcutenous injection at low back portion during labor pain
    Arm Title
    saline injection
    Arm Type
    Experimental
    Arm Description
    Subcutenous injection at low back portion during labor pain
    Intervention Type
    Other
    Intervention Name(s)
    Subcutaneous sterile water injection
    Other Intervention Name(s)
    sterile water injection
    Intervention Description
    sterile water injection in two points of low back pain
    Intervention Type
    Other
    Intervention Name(s)
    saline injection
    Other Intervention Name(s)
    Natural pain relief
    Intervention Description
    Saline injection in two points of low back pain
    Primary Outcome Measure Information:
    Title
    Pain relief
    Description
    the investigator spend two hours with each client to measure the effect of pain relief
    Time Frame
    two hours for each client
    Title
    Women's Saisfaction
    Description
    measuring pain relief within different minutes
    Time Frame
    each 15 min until 120 min

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Protocol or seminar discussion

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    Subcutaneous Sterile Water Injection for Relief of Low Back Pain

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