Sterile Water Injections For Pain Relief İn Labor

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697994
• Other study ID #: SWI1315
• Status: Completed
• Phase: N/A
• First received: February 9, 2016
• Last updated: March 2, 2016
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: February 2016
• Source: University of Beykent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Infertility
• Labor Pain
• Labour Pain

Intervention

Other:
• Sterile Water
0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.
• Dry Injections
dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Beykent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores-30	In pain scoring Visual Analog Scale was used	at 30 mins after interventions
Secondary	Pain scores-10	In pain scoring Visual Analog Scale was used	at 10 mins after interventions
Secondary	Pain scores-60	In pain scoring Visual Analog Scale was used	at 60 mins after interventions
Secondary	Pain scores-90	In pain scoring Visual Analog Scale was used	at 90 mins after interventions
Secondary	Pain scores-120	In pain scoring Visual Analog Scale was used	at 120 mins after interventions
Secondary	Pain scores-180	In pain scoring Visual Analog Scale was used	at 180 mins after interventions
Secondary	APGAR score of neonate		at 5 mins after birth
Secondary	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
Secondary	Rates of breastfeeding-1	In breastfeed scoring The Infant Breastfeeding Assessment Tool was used	at 1 hour after birth
Secondary	Rates of breastfeeding-24	In breastfeed scoring The Infant Breastfeeding Assessment Tool was used	at 24.hours after birth