search
Back to results

Sterile Water Injections For Pain Relief İn Labor

Primary Purpose

Labour Pain, Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sterile Water
Dry Injections
Sponsored by
University of Beykent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labour Pain focused on measuring Sterile Water Injection, Midwifery

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sterile Water Injection

    Dry Injection

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Pain scores-30
    In pain scoring Visual Analog Scale was used

    Secondary Outcome Measures

    Pain scores-10
    In pain scoring Visual Analog Scale was used
    Pain scores-60
    In pain scoring Visual Analog Scale was used
    Pain scores-90
    In pain scoring Visual Analog Scale was used
    Pain scores-120
    In pain scoring Visual Analog Scale was used
    Pain scores-180
    In pain scoring Visual Analog Scale was used
    APGAR score of neonate
    Maternal satisfaction
    Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others
    Rates of breastfeeding-1
    In breastfeed scoring The Infant Breastfeeding Assessment Tool was used
    Rates of breastfeeding-24
    In breastfeed scoring The Infant Breastfeeding Assessment Tool was used

    Full Information

    First Posted
    February 9, 2016
    Last Updated
    March 2, 2016
    Sponsor
    University of Beykent
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02697994
    Brief Title
    Sterile Water Injections For Pain Relief İn Labor
    Official Title
    Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Beykent

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labour Pain, Back Pain
    Keywords
    Sterile Water Injection, Midwifery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    168 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sterile Water Injection
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Dry Injection
    Arm Type
    Placebo Comparator
    Arm Description
    Participants in the control group received 4 dry injections in the same region using an insulin needle .
    Intervention Type
    Other
    Intervention Name(s)
    Sterile Water
    Intervention Description
    0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.
    Intervention Type
    Other
    Intervention Name(s)
    Dry Injections
    Intervention Description
    dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.
    Primary Outcome Measure Information:
    Title
    Pain scores-30
    Description
    In pain scoring Visual Analog Scale was used
    Time Frame
    at 30 mins after interventions
    Secondary Outcome Measure Information:
    Title
    Pain scores-10
    Description
    In pain scoring Visual Analog Scale was used
    Time Frame
    at 10 mins after interventions
    Title
    Pain scores-60
    Description
    In pain scoring Visual Analog Scale was used
    Time Frame
    at 60 mins after interventions
    Title
    Pain scores-90
    Description
    In pain scoring Visual Analog Scale was used
    Time Frame
    at 90 mins after interventions
    Title
    Pain scores-120
    Description
    In pain scoring Visual Analog Scale was used
    Time Frame
    at 120 mins after interventions
    Title
    Pain scores-180
    Description
    In pain scoring Visual Analog Scale was used
    Time Frame
    at 180 mins after interventions
    Title
    APGAR score of neonate
    Time Frame
    at 5 mins after birth
    Title
    Maternal satisfaction
    Description
    Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others
    Time Frame
    at 1 hour after birth
    Title
    Rates of breastfeeding-1
    Description
    In breastfeed scoring The Infant Breastfeeding Assessment Tool was used
    Time Frame
    at 1 hour after birth
    Title
    Rates of breastfeeding-24
    Description
    In breastfeed scoring The Infant Breastfeeding Assessment Tool was used
    Time Frame
    at 24.hours after birth

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Sterile Water Injections For Pain Relief İn Labor

    We'll reach out to this number within 24 hrs