NCT00547807

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

February 26, 2009

Status Verified

February 1, 2009

Enrollment Period

2.1 years

First QC Date

October 22, 2007

Last Update Submit

February 25, 2009

Conditions

Pain

Keywords

Pain, neonate, nursing care

Outcome Measures

Primary Outcomes (1)

  • pain score

    pre painfull procedure

Interventions

Non-nutritive suckingOTHER

Non-nutritive sucking is applied by using a gloved finger

Also known as: complementary therapy
SwaddlingOTHER

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 Criteria

Age2 Days - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term healthy neonates

You may not qualify if:

  • NICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sociedade Hospital Samaritano

São Paulo, São Paulo, 01232-010, Brazil

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mariana Bueno, MSN

    Sociedade Hospital Samaritano

    PRINCIPAL INVESTIGATOR

  • Edna A Bussotti, RN

    Sociedade Hospital Samaritano

    PRINCIPAL INVESTIGATOR

  • Andréia Silva, RN

    Sociedade Hospital Samaritano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliseth R Leão, PhD

CONTACT

55 11 38215891eliseth.leao@samaritano.org.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 23, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2009

Last Updated

February 26, 2009

Record last verified: 2009-02

Locations

BR(1)