CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
music therapy selected by mothers +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02434432
NCT02434432N/ACompleted

Music Therapy as a Method of Non-Pharmacological Pain Management in the NICU Setting

American University of Beirut Medical Center·interventional·Posted May 5, 2015·Updated May 5, 2015

In Brief

A clinical study evaluating music therapy selected by mothers and Music therapy recorded lullaby for Music Therapy. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMusic Therapy
CountriesLebanon
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 5, 2015
Enrollment StartJan 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.2 years ago

Interventions

music therapy selected by mothersbehavioral

mothers' choice of music

Music therapy recorded lullabybehavioral

recorded lullaby