Sterile Water Injections For Pain Relief İn Labor

Not Applicable

Completed

• Conditions: Labour Pain; Back Pain
• Interventions: Other: Dry Injections; Other: Sterile Water

• Registration Number: NCT02697994
• Lead Sponsor: University of Beykent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-03-02
• Last Update Submitted: 2016-03-02
• Study First Posted: 2016-03-03
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Injection	Dry Injections	Participants in the control group received 4 dry injections in the same region using an insulin needle .
Sterile Water Injection	Sterile Water	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.

Primary Outcome Measures

Name	Time	Method
Pain scores-30	at 30 mins after interventions	In pain scoring Visual Analog Scale was used

Secondary Outcome Measures

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