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

This study is currently recruiting participants.

Verified by Sociedade Hospital Samaritano, May 2008

Sponsored by:	Sociedade Hospital Samaritano
Information provided by:	Sociedade Hospital Samaritano
ClinicalTrials.gov Identifier:	NCT00547807

Purpose

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.

Condition	Intervention
Pain	Other: Non-nutritive sucking Other: Swaddling

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Sociedade Hospital Samaritano:

Primary Outcome Measures:

pain score [ Time Frame: pre painfull procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	34
Study Start Date:	January 2007
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Nonnutritive sucking is applied by using a gloved finger

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

Eligibility

Ages Eligible for Study:	up to 5 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Term healthy neonates

Exclusion Criteria:

NICU admission

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547807

Contacts

Contact: Eliseth R Leão, PhD

55 11 38215891

eliseth.leao@samaritano.org.br

Locations

Brazil, SP
Sociedade Hospital Samaritano	Recruiting
São Paulo, SP, Brazil, 01232-010
Contact: Eliseth R Leão, PhD 55 11 38215891 eliseth.leao@samaritano.org.br

Sponsors and Collaborators

Sociedade Hospital Samaritano

Investigators

Principal Investigator:	Mariana Bueno, MSN	Sociedade Hospital Samaritano
Principal Investigator:	Edna A Bussotti, RN	Sociedade Hospital Samaritano
Principal Investigator:	Andréia Silva, RN	Sociedade Hospital Samaritano

More Information

Responsible Party:	HCFMUSP ( Mariana Bueno )
Study ID Numbers:	SHS 52/06
Study First Received:	October 22, 2007
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00547807
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Sociedade Hospital Samaritano:

Pain, neonate, nursing care

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on February 09, 2009