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
Recruitment status was Recruiting
Sponsor:
Sociedade Hospital Samaritano
Information provided by:
Sociedade Hospital Samaritano
ClinicalTrials.gov Identifier:
NCT00547807
First received: October 22, 2007
Last updated: February 25, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 22, 2013