Subcutaneous Sterile Water Injection for Relief of Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-06-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Sterile Water injection

Subcutenous injection at low back portion during labor pain

Group Type EXPERIMENTAL

Subcutaneous sterile water injection

Intervention Type OTHER

sterile water injection in two points of low back pain

saline injection

Intervention Type OTHER

Saline injection in two points of low back pain

saline injection

Subcutenous injection at low back portion during labor pain

Group Type EXPERIMENTAL

Subcutaneous sterile water injection

Intervention Type OTHER

sterile water injection in two points of low back pain

saline injection

Intervention Type OTHER

Saline injection in two points of low back pain

Interventions

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Subcutaneous sterile water injection

sterile water injection in two points of low back pain

Intervention Type OTHER

saline injection

Saline injection in two points of low back pain

Intervention Type OTHER

Other Intervention Names

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sterile water injection Natural pain relief

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes