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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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
  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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mariana Bueno, HCFMUSP
ClinicalTrials.gov Identifier: NCT00547807     History of Changes
Other Study ID Numbers: SHS 52/06
Study First Received: October 22, 2007
Last Updated: February 25, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on July 26, 2014