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Music Therapy for Pain Management in the NICU Setting

NCT02434432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-05

No results posted yet for this study

Summary

Background: Music therapy has been recommended as an adjuvant therapy for both preterm infants and mothers throughout their stay in the Neonatal Intensive Care Unit (NICU), and has been shown to have some beneficial effects, although conclusive evidence remains lacking.

Objectives: To study the usefulness of two forms of music, as well as no music, on pain and physiological and behavioral parameters of preterm infants during a heel stick procedure for obtaining blood in the Neonatal Intensive Care Unit (NICU).

Hypotheses: Infants hearing music chosen by their mothers will have less pain and optimal behavioral and physiologic responses as compared to infants who hear the lullaby or no music.

Methods: An analytical observational study with a randomized cross-over design will be utilized.

Inclusion will be stable infants born between 28 to 36 weeks of gestation, with normal hearing. Neonatal Physiologic responses \[heart rate (HR), oxygen saturation, (02 sat) and respiratory rate(RR)\] and Behavioral States will be recorded before and after the heel stick procedure. Maternal age, education, and pregnancy complications will be also be documented. Pain responses will be recorded using the Neonatal Pain, Agitation and Sedation Scale (NPASS).

Ethical considerations: The study imposes minimal risk on infants. One potential risk is that the infant may become agitated while listening to music, especially if it is time for feeding. Based on previous research, infants tend to calm down while listening to music. However, in the infants who may be hungry or fussy, music exacerbate their agitation. To prevent this from occurring the investigators will not perform the heel stick close to feeding time and the investigators will be vigilantly timing and monitoring the infant's agitation. Because music has been shown to calm infants and stop them from crying, the benefits outweigh this risk.

The heel stick is performed routinely on infants (often 3-6 times a day). The investigators will not perform any additional heel sticks for this study, but will rather intervene during one of the scheduled heel stick procedures.

Conditions

  • Music Therapy

Interventions

BEHAVIORAL

music therapy selected by mothers

mothers' choice of music

BEHAVIORAL

Music therapy recorded lullaby

recorded lullaby

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
28 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02434432 on ClinicalTrials.gov