Sterile Water Injections For Pain Relief İn Labor

March 2, 2016 updated by: refika genç koyucu, University of Beykent

Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial

ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases.

Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged between 18-35
  • 37-42 weeks of gestation
  • Expecting vaginal delivery
  • Cephalic presentation
  • Single, healthy fetus
  • Spontaneous onset of labor
  • Active phase of first stage of labor (3-7 cm cervical dilatation)
  • Severe low back pain (VAS>7cm)
  • Required pain relief

Exclusion Criteria:

  • Gestation <37 weeks
  • Multiple pregnancy
  • Malpresentation
  • Second stage labour
  • Pharmacological analgesia prior to SWI
  • Back pain assessed by VAS <7
  • Women whose labour would be considered high risk

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sterile Water Injection
Participants randomised to the intervention group received 4 intracutaneous injections of 0.1 ml sterile water into the skin surrounding the Michaelis rhomboid over the sacral area.
Other: Sterile Water
0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.
Placebo Comparator: Dry Injection
Participants in the control group received 4 dry injections in the same region using an insulin needle .
Other: Dry Injections
dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores-30
Time Frame: at 30 mins after interventions
In pain scoring Visual Analog Scale was used
at 30 mins after interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores-10
Time Frame: at 10 mins after interventions
In pain scoring Visual Analog Scale was used
at 10 mins after interventions
Pain scores-60
Time Frame: at 60 mins after interventions
In pain scoring Visual Analog Scale was used
at 60 mins after interventions
Pain scores-90
Time Frame: at 90 mins after interventions
In pain scoring Visual Analog Scale was used
at 90 mins after interventions
Pain scores-120
Time Frame: at 120 mins after interventions
In pain scoring Visual Analog Scale was used
at 120 mins after interventions
Pain scores-180
Time Frame: at 180 mins after interventions
In pain scoring Visual Analog Scale was used
at 180 mins after interventions
APGAR score of neonate
Time Frame: at 5 mins after birth
at 5 mins after birth
Maternal satisfaction
Time Frame: at 1 hour after birth
Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others
at 1 hour after birth
Rates of breastfeeding-1
Time Frame: at 1 hour after birth
In breastfeed scoring The Infant Breastfeeding Assessment Tool was used
at 1 hour after birth
Rates of breastfeeding-24
Time Frame: at 24.hours after birth
In breastfeed scoring The Infant Breastfeeding Assessment Tool was used
at 24.hours after birth

Collaborators and Investigators

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

Sponsor

University of Beykent

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

June 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWI1315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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