Subcutaneous Sterile Water Injection for Relief of Low Ba... | NCT02813330

Studies
Subcutaneous Sterile Water Injection for Relief of Low Back Pain

NCT02813330

Sponsor

Woman's Health University Hospital, Egypt

Status

Unknown status

Last Update Posted

Jun 27, 2016Estimated

Enrollment

336Actual

Phase

Phase 1Phase 2

Conditions

Low Back Pain

Interventions

Subcutaneous sterile water injection
saline injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Jun 18, 2016

First Submission Date that Met QC Criteria

Jun 21, 2016

First Posted Date

Jun 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2016

Last Update Posted Date

Jun 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Howieda Fouly, PhD, Lecturer of Obstetric & gynecological nursing, Woman's Health University Hospital, EgyptPrincipal Investigator

Lead Sponsor

Woman's Health University Hospital, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Study sample:

The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection)

Setting:

Labor ward in Women's health center at Assiut university hospital

Study design:

Experimental Randomized control study

Sample size:

The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria

In labour (spontaneous or induced
During first stageof 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 ( Warden V, Hurley AC, Volicer L.2003)
Provide informed consent.

Exclusion criteria

Multiple pregnancy
Malpresentation (breech, transverse, shoulder)
Previous CS
Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.

Study Tools:

Personal data questionnaire
Visual Analogue Scale and Face analogue scale
Satisfaction scale

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

336Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sterile Water injection	Experimental	Subcutenous injection at low back portion during labor pain	Other: Subcutaneous sterile water injection Other: saline injection
saline injection	Experimental	Subcutenous injection at low back portion during labor pain	Other: Subcutaneous sterile water injection Other: saline injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous sterile water injection	Other	sterile water injection in two points of low back pain	Sterile Water injection saline injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Women with chronic disease
Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc)
Complicated labor process ( obstructed, preterm labor, twins)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Protocol or seminar discussion

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Nov 1, 2017
Reset	Aug 3, 2018
Release	Oct 23, 2020
Reset	Nov 16, 2020

Submission Tracking

Estimated Results First Submitted Date

Nov 1, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 1, 2017			Aug 3, 2018
Oct 23, 2020

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided