Sterile Water Injections For Pain Relief İn Labor

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: Back Pain; Labour Pain
• Intervention / Treatment: Other: Sterile Water; Other: Dry Injections

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	In pain scoring Visual Analog Scale was used	at 10 mins after interventions
Pain scores-60	In pain scoring Visual Analog Scale was used	at 60 mins after interventions
Pain scores-90	In pain scoring Visual Analog Scale was used	at 90 mins after interventions
Pain scores-120	In pain scoring Visual Analog Scale was used	at 120 mins after interventions
Pain scores-180	In pain scoring Visual Analog Scale was used	at 180 mins after interventions
APGAR score of neonate		at 5 mins after birth
Maternal satisfaction	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	In breastfeed scoring The Infant Breastfeeding Assessment Tool was used	at 1 hour after birth
Rates of breastfeeding-24	In breastfeed scoring The Infant Breastfeeding Assessment Tool was used	at 24.hours after birth

Collaborators and Investigators

• Sponsor: University of Beykent

Study record dates

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: Midwifery; Sterile Water Injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infertility; Labor Pain
• Other Study ID Numbers: SWI1315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided