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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Sociedade Hospital Samaritano.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sociedade Hospital Samaritano
ClinicalTrials.gov Identifier:
NCT00547807
First received: October 22, 2007
Last updated: February 25, 2009
Last verified: February 2009
History of Changes

October 22, 2007
February 25, 2009
January 2007
February 2009   (final data collection date for primary outcome measure)
pain score [ Time Frame: pre painfull procedure ] [ Designated as safety issue: Yes ]
pain score
Complete list of historical versions of study NCT00547807 on ClinicalTrials.gov Archive Site
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Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: Randomised Controlled Trial
Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: a Randomised Controlled Trial

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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
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February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Term healthy neonates

Exclusion Criteria:

  • NICU admission
Both
up to 5 Days
No
Contact: Eliseth R Leão, PhD 55 11 38215891 eliseth.leao@samaritano.org.br
Brazil
 
NCT00547807
SHS 52/06
No
Mariana Bueno, HCFMUSP
Sociedade Hospital Samaritano
Not Provided
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
Sociedade Hospital Samaritano
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP