Subcutaneous Sterile Water Injection for Relief of Low Back Pain
1 other identifier
interventional
336
0 countries
N/A
Brief Summary
To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 low-back-pain
Started Feb 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 18, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedJune 27, 2016
June 1, 2016
1.3 years
June 18, 2016
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain relief
the investigator spend two hours with each client to measure the effect of pain relief
two hours for each client
Women's Saisfaction
measuring pain relief within different minutes
each 15 min until 120 min
Study Arms (2)
Sterile Water injection
EXPERIMENTALSubcutenous injection at low back portion during labor pain
saline injection
EXPERIMENTALSubcutenous injection at low back portion during labor pain
Interventions
sterile water injection in two points of low back pain
Saline injection in two points of low back pain
Eligibility Criteria
You may qualify if:
- In labour (spontaneous or induced record
- During first stage of labour
- Primary and multiparous women
- A term singleton pregnancy (between 37 + 0 and 41 weeks)
- Have a fetus in a cephalic presentation
- Experience back pain assessed by visual analogue scale VAS and Face pain analogue
- Provide informed consent.
You may not qualify if:
- Women with chronic disease
- Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc)
- Complicated labor process ( obstructed, preterm labor, twins)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Lecturer of Obstetric & gynecological nursing
Study Record Dates
First Submitted
June 18, 2016
First Posted
June 27, 2016
Study Start
February 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 27, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will share
Protocol or seminar discussion