Sterile Water Injections For Pain Relief İn Labor

NCT02697994 | Completed

• 1 other identifier: SWI1315
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Labour Pain; Back Pain

Keywords

Sterile Water Injection; Midwifery

Outcome Measures

Primary Outcomes (1)

• Pain scores-30

  In pain scoring Visual Analog Scale was used

  at 30 mins after interventions

Secondary Outcomes (9)

• Pain scores-10

  at 10 mins after interventions

• Pain scores-60

  at 60 mins after interventions

• Pain scores-90

  at 90 mins after interventions

• Pain scores-120

  at 120 mins after interventions

• Pain scores-180

  at 180 mins after interventions

Study Arms (2)

Sterile Water Injection

EXPERIMENTAL

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

Dry Injection

PLACEBO COMPARATOR

Participants in the control group received 4 dry injections in the same region using an insulin needle .

Other: Dry Injections

Interventions

Sterile Water OTHER

0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.

Sterile Water Injection

Dry Injections OTHER

dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.

Dry Injection

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18-35
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Beykent: lead

MeSH Terms

Conditions

Labor Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist.prof.

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: March 3, 2016
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 3, 2016

Record last verified: 2016-02