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

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ClinicalTrials.gov Identifier: NCT00547807
Recruitment Status : Unknown
Verified February 2009 by Sociedade Hospital Samaritano.
Recruitment status was:  Recruiting
First Posted : October 23, 2007
Last Update Posted : February 26, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Pain Other: Non-nutritive sucking Other: Swaddling

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: a Randomised Controlled Trial
Study Start Date : January 2007
Primary Completion Date : February 2009
Arms and Interventions

Intervention Details:
    Other: Non-nutritive sucking
    Non-nutritive sucking is applied by using a gloved finger
    Other Name: complementary therapy
    Other: Swaddling
    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

Outcome Measures

Primary Outcome Measures :
  1. pain score [ Time Frame: pre painfull procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term healthy neonates

Exclusion Criteria:

  • NICU admission
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547807


Contacts
Contact: Eliseth R Leão, PhD 55 11 38215891 eliseth.leao@samaritano.org.br

Locations
Brazil
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: Mariana Bueno, HCFMUSP
ClinicalTrials.gov Identifier: NCT00547807     History of Changes
Other Study ID Numbers: SHS 52/06
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: February 26, 2009
Last Verified: February 2009

Keywords provided by Sociedade Hospital Samaritano:
Pain, neonate, nursing care