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
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
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
NCT ID
NCT02813330
First Posted
June 18, 2016
Last Updated
June 21, 2016
Sponsor
Woman's Health University Hospital, Egypt
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
Learn more about this trial
Subcutaneous Sterile Water Injection for Relief of Low Back Pain
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