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Music Therapy for Pain Management in the NICU Setting (MTP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434432
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
American University of Beirut Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Music Therapy Behavioral: music therapy selected by mothers Behavioral: Music therapy recorded lullaby Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Music Therapy as a Method of Non-Pharmacological Pain Management in the NICU Setting
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: condition 1
Infants in this arm will receive their mother's choice of music recorded on an Mp player and delivered via headphones.
Behavioral: music therapy selected by mothers
mothers' choice of music
Other Name: condition 1

Active Comparator: condition 2
Infants in this arm wil receive a recorded Lullaby music delivered to the infant via headphones.
Behavioral: Music therapy recorded lullaby
recorded lullaby
Other Name: condition 2

No Intervention: Condition 3
Infants in this arm will have the headphones applied but no music played.



Primary Outcome Measures :
  1. pain responses of preterm infants assessed on the NPASS [ Time Frame: During a heelstick procedure 5 minutes after the music conditions 1 & 2 or the control ]

Secondary Outcome Measures :
  1. Physiologic resposnes [ Time Frame: 5 minutes before, during and five minutes after the heelstick ]
    Physiologic responses: Heart rate, Respiratory rate and Oxygen saturations recorded 5 munites before, during, and 5 minutes after the heelstick.

  2. Behavioral responses [ Time Frame: Recorded at 5 minutes before during and five minutes after the heelstick ]
    Behavioral responses recorded using the Brazelton behavioral scale; 5 minutes before during and five minutes after the heelstick



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Ages Eligible for Study:   28 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants will be included if they meet the following criteria: between 28 to 36 weeks gestational age, stable condition, not requiring any respiratory support, in an isolette or open crib, are at least one week post natal age and if their mothers have listened to music while pregnant.

Exclusion Criteria:

  • Infant will be excluded if they are intubated and on a ventilator or high frequency ventilation, if they have a congenital anomaly that mainly affects hearing, such as craniofacial anomalies; and if they have brain anomalies associated with neurological disorders such as: grade 3-4 intraventricular hemorrhage and periventricular leukomalacia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434432


Locations
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Lebanon
American University Medical Center (AUBMC)
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Publications:

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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02434432    
Other Study ID Numbers: NUR.LB.02
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015