Abstract
Although many musical intervention studies exist in the wider framework of neuroscience and psychology, the preliminary importance of feasibility studies is rarely discussed. Adding to this fact the limited research existing on the therapeutic and restorative potential of music exposure during early developmental periods, pushed us to concentrate on investigating newborns’ perception of music and its impact on the brain. Here, we explore the feasibility of a randomized controlled trial (RCT) approach when measuring and comparing the neurophysiological perception of music versus language on the brainstem of newborns using auditory brainstem response (ABR). Twenty-five healthy full-term infants were recruited, eight of which were measured within their first 10 days postpartum. The evaluation of the study’s feasibility appealed to five main objectives that essentially answer the question: Can our protocol work? Each objective proposes questions based on Orsmond and Cohn’s guiding framework, designed to assess, and assist feasibility in understanding barriers toward a study’s success. Our results justify that newborns are well capable of undergoing the study and given meticulous considerations and improvements on the intervention resources. The procedure’s communication and technical obstacles are resoluble. Moreover, assimilation of external factors to adapt, such as the culture variation and the ABR protocol implementation are necessary. The study was well received in the selected region (Middle East), and the recording procedure showed potential outcomes for a comprehensive RCT.
Highlights
A large number of musical intervention studies exist in the wider framework of neuroscience and psychology, the preliminary importance of feasibility studies is rarely discussed—and used—by researchers in the specific field
According to the National Institute of Health Research [12] pilot studies are ‘smaller versions of the main study used to test whether the components of the main study can all work together’, whereas feasibility studies focus on conducting novel research and examine whether a study can be done and fitting to the area of application
The feasibility stage we report here, employed a well-defined set of objectives to pinpoint and extract valuable data to consider while applying our protocol, and aimed to understand the extent to which our research design is able to produce viable results, while perceiving, documenting and analyzing in detail the changes that can or should be made in the data collection process, and suggest a better implementation of our intervention and measurement tools
Summary
A large number of musical intervention studies exist in the wider framework of neuroscience and psychology (for example see reviews [1,2,3,4,5,6,7]), the preliminary importance of feasibility studies is rarely discussed—and used—by researchers in the specific field. It has been suggested that feasibility studies are better suited to make us understand the challenges in the implementation of newly constructed intervention tools, while enabling us to more reliably bring a research design into the field [11]. According to the National Institute of Health Research [12] pilot studies are ‘smaller versions of the main study used to test whether the components of the main study can all work together’, whereas feasibility studies focus on conducting novel research and examine whether a study can be done and fitting to the area of application. The distinctive feature of feasibility studies, focuses on the process to answer the question “can it work?”, whereas the distinctive feature of pilot studies focuses on the outcome “does the intervention show promise?” [13]
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