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NCT00547807 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00547807
Other study ID # SHS 52/06
Secondary ID
Status Unknown status
Phase N/A
First received October 22, 2007
Last updated February 25, 2009
Start date January 2007

Study information
Verified date February 2009
Source Sociedade Hospital Samaritano
Contact Eliseth R Leão, PhD
Phone 55 11 38215891
Email eliseth.leao@samaritano.org.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 34
Est. completion date
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Days
Eligibility Inclusion Criteria:

- Term healthy neonates

Exclusion Criteria:

- NICU admission

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-nutritive sucking
Non-nutritive sucking is applied by using a gloved finger
• 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

Locations
Country Name City State
Brazil Sociedade Hospital Samaritano São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
Sociedade Hospital Samaritano

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain score pre painfull procedure
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