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

NCT ID: NCT00547807

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Keywords

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Pain, neonate, nursing care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Non-nutritive sucking

Non-nutritive sucking is applied by using a gloved finger

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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complementary therapy

Eligibility Criteria

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Inclusion Criteria

* Term healthy neonates

Exclusion Criteria

* NICU admission
Minimum Eligible Age

2 Days

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedade Hospital Samaritano

OTHER

Sponsor Role lead

Responsible Party

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HCFMUSP

Principal Investigators

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Mariana Bueno, MSN

Role: PRINCIPAL_INVESTIGATOR

Sociedade Hospital Samaritano

Edna A Bussotti, RN

Role: PRINCIPAL_INVESTIGATOR

Sociedade Hospital Samaritano

Andréia Silva, RN

Role: PRINCIPAL_INVESTIGATOR

Sociedade Hospital Samaritano

Locations

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Sociedade Hospital Samaritano

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Eliseth R Leão, PhD

Role: CONTACT

Phone: 55 11 38215891

Email: [email protected]

Facility Contacts

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Eliseth R Leão, PhD

Role: primary

Other Identifiers

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SHS 52/06

Identifier Type: -

Identifier Source: org_study_id