Subcutaneous Sterile Water Injection for Relief of Low Back Pain

June 21, 2016 updated by: Howieda Fouly, Woman's Health University Hospital, Egypt

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • sterile water injection
Other: saline injection
Saline injection in two points of low back pain
Other Names:
  • 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 Names:
  • sterile water injection
Other: saline injection
Saline injection in two points of low back pain
Other Names:
  • Natural pain relief

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Woman's Health University Hospital, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 18, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Women Health Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Protocol or seminar discussion

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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