"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

Brief Summary

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"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants.

Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units.

Such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. However, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. Current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. To date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. The "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. This intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.

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Detailed Description

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Conditions

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Blood Sampling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Holding-cuddling + Sucrose

The Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling.

Group Type EXPERIMENTAL

Holding-cuddling

Intervention Type PROCEDURE

The "Holding-cuddling" is started 5 minutes before veinipuncture.

Sucrose

Intervention Type PROCEDURE

The sucrose adminstration is started 2 minutes before veinipuncture.

Sucrose alone

The sucrose administration is started 2 minutes before blood sampling.

Group Type ACTIVE_COMPARATOR

Sucrose

Intervention Type PROCEDURE

The sucrose adminstration is started 2 minutes before veinipuncture.

Interventions

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