Non-Nutritive Sucking and Swaddling for Pain Relief in Te... | NCT00547807

Studies
Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: Randomised Controlled Trial

NCT00547807

Sponsor

Sociedade Hospital Samaritano

Status

Unknown status

Last Update Posted

Feb 26, 2009Estimated

Enrollment

34Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Non-nutritive sucking
Swaddling

Countries

Brazil

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Not provided

First Submitted Date

Oct 22, 2007

First Submission Date that Met QC Criteria

Oct 22, 2007

First Posted Date

Oct 23, 2007Estimated

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

Feb 25, 2009

Last Update Posted Date

Feb 26, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Non pharmacological approaches are important in pain control in neonates, specially in term healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for pain control in these population, but the effect in their association are not clear until now. The hypothesis of the study is that association between non-nutritive sucking and swaddling reduces pain scores resulting from venepuncture compared to non-nutritive sucking alone.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-nutritive sucking	Other	Non-nutritive sucking is applied by using a gloved finger		complementary therapy
Swaddling	Other	Swaddling is an age-old practice of wrapping infants snugly in swaddling cloths, blankets or similar cloth so that movement of the limbs is tightly restricted

Measure	Description	Time Frame
pain score		pre painfull procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Term healthy neonates

Exclusion Criteria:

NICU admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Days

Maximum Age

5 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eliseth R Leão, PhD	Contact	55 11 38215891		eliseth.leao@samaritano.org.br

Overall Officials

Name	Affiliation	Role
Mariana Bueno, MSN	Sociedade Hospital Samaritano	Principal Investigator
Edna A Bussotti, RN	Sociedade Hospital Samaritano	Principal Investigator
Andréia Silva, RN

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sociedade Hospital Samaritano	Recruiting	São Paulo	São Paulo	01232-010	Brazil

Type	Date	Date Unknown
Release	Aug 27, 2009
Unrelease		Yes
Release	Aug 31, 2009
Reset	Sep 30, 2009
Release	Oct 9, 2009
Reset	Nov 10, 2009
Release	May 25, 2012
Reset	Jun 28, 2012

Submission Tracking

Estimated Results First Submitted Date

Aug 27, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 27, 2009		Yes
Aug 31, 2009

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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