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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. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Sociedade Hospital Samaritano.
Recruitment status was:  Recruiting
Information provided by:
Sociedade Hospital Samaritano Identifier:
First received: October 22, 2007
Last updated: February 25, 2009
Last verified: February 2009
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
Other: Non-nutritive sucking
Other: Swaddling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: a Randomised Controlled Trial

Further study details as provided by Sociedade Hospital Samaritano:

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

Estimated Enrollment: 34
Study Start Date: January 2007
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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

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

Inclusion Criteria:

  • Term healthy neonates

Exclusion Criteria:

  • NICU admission
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00547807

Contact: Eliseth R Leão, PhD 55 11 38215891

Sociedade Hospital Samaritano Recruiting
São Paulo, SP, Brazil, 01232-010
Contact: Eliseth R Leão, PhD    55 11 38215891   
Sponsors and Collaborators
Sociedade Hospital Samaritano
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 Identifier: NCT00547807     History of Changes
Other Study ID Numbers: SHS 52/06
Study First Received: October 22, 2007
Last Updated: February 25, 2009

Keywords provided by Sociedade Hospital Samaritano:
Pain, neonate, nursing care processed this record on May 25, 2017