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Subcutaneous Sterile Water Injection for Relief of Low Back Pain

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ClinicalTrials.gov Identifier: NCT02813330
Recruitment Status : Unknown
Verified June 2016 by Howieda Fouly, Woman's Health University Hospital, Egypt.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Howieda Fouly, 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

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Subcutaneous sterile water injection Other: saline injection Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Subcutaneous Sterile Water Injection for Relief of Low Back Pain During Normal Labor: Randomized Controlled Study
Study Start Date : February 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sterile Water injection
Subcutenous injection at low back portion during labor pain
Other: Subcutaneous sterile water injection
sterile water injection in two points of low back pain
Other Name: sterile water injection

Other: saline injection
Saline injection in two points of low back pain
Other Name: Natural pain relief

Experimental: saline injection
Subcutenous injection at low back portion during labor pain
Other: Subcutaneous sterile water injection
sterile water injection in two points of low back pain
Other Name: sterile water injection

Other: saline injection
Saline injection in two points of low back pain
Other Name: Natural pain relief




Primary Outcome Measures :
  1. Pain relief [ Time Frame: two hours for each client ]
    the investigator spend two hours with each client to measure the effect of pain relief

  2. Women's Saisfaction [ Time Frame: each 15 min until 120 min ]
    measuring pain relief within different minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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)
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Responsible Party: Howieda Fouly, PhD, Lecturer of Obstetric & gynecological nursing, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT02813330    
Other Study ID Numbers: Women Health Hospital
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Protocol or seminar discussion
Keywords provided by Howieda Fouly, Woman's Health University Hospital, Egypt:
Women
severe
low back ache
labor
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations