In prior studies, anxiety and musical exposure was investigated, but yielded results
showing both a decrease in anxiety and increase in anxiety. As such, it is possible that
there is a "dose" of musical exposure that would achieve optimal anti-anxiety effects,
with decreasing efficacy when undershot or overshot. In previous studies, it has been
demonstrated that specific selections of Mozart Sonata's, composed with specific rhythms
and modes have helped improve patient anxiety through patient mechanisms. As such, this
study will continue to use music described in Conrad's previous studies not only as a
control mechanism for exposure, but also utilizing already established principals and
groundwork.
Once the subject is recruited, patient demographic data and baseline vital signs
(including anxiety levels) will be recorded from the patient charts that have been filled
out by the patient's provider. Anxiety assessment will be on a scale of 0-10 and the
patient will simply be asked to rate their anxiety on that scale, with 0 being absolutely
no anxiety and a 10 being the most anxious they have ever felt.
In the exposure group, an investigator will come in with a stereo music player with
external speakers that will have the musical pieces pre-loaded. The investigator will be
in charge of setting up the music player and starting the music. The patients will then
proceed with their predetermined listening time of music. Upon completion, vital signs
(including anxiety levels) will once again be collected by the patient's providers and
recorded by the investigator. The investigator will also ask a few questions that assess
the patient's experience throughout the study and their experience with listening to and
playing musical instruments.
In the control group, an investigator will proceed with a predetermined time of no music.
Participants and supporting staff would be asked not to play music in the room during the
observed time. Upon completion, vital signs (including anxiety levels) will once again be
collected by the patient's providers and recorded by the investigator. The investigator
will also ask a few questions that assess the patient's experience throughout the study
and their experience with listening to and playing musical instruments.
This study will be performing an Up-Down sequential allocation study using Dixon's method
to estimate the minimum dose, which provides a 50% chance of reducing anxiety.
Specifically, the investigators will start at a musical exposure of 15 minutes for the
first study participant. Upon collecting the first participant's anxiety score post-music
exposure, the differences in pre-exposure and post-exposure anxiety scores will be
calculated. The second study participant will have their exposure time "stepped up" or
increased, by 5 minutes if the first study subject results in a failure, defined as
either no change or an increase in their post-exposure anxiety. If there was a decrease
in anxiety post-exposure, or a "success", then the second subject will have their
exposure time reduced by 5 minutes, or "stepped down". From there, the third
participant's exposure time will be adjusted based on the outcomes of the second
participant. This method and pattern will be applied for all subsequent participants in
order to find the lowest duration of music exposure to achieve an effective dose.
The same Up-Down sequential allocation study method will be utilized for the control
group. Specifically, the investigators will start with no-music exposure of 15 minutes
for the first study participant. Upon collecting the first participant's anxiety score
post-no-music exposure, the differences in pre-exposure and post-exposure anxiety scores
will be calculated. The second study participant will have their exposure time "stepped
up" or increased, by 5 minutes if the first study subject results in a failure, defined
as either no change or an increase in their post-exposure anxiety. If there was a
decrease in anxiety post-exposure, or a "success", then the second subject will have
their exposure time reduced by 5 minutes, or "stepped down". From there, the third
participant's exposure time will be adjusted based on the outcomes of the second
participant. This method and pattern will be applied for all subsequent participants in
order to find the lowest duration of music exposure to achieve an effective dose.
The absolute minimal musical exposure time will be set at 1 minute and if the effective
dose is achieved at 1 minute, the investigators will start each subsequent patient at 1
minute of musical exposure. After the first 5-minute exposure is achieved, from either
success or failures, the time increments will be adjusted by increments of 1 minute
instead of the previous 5. For example, a failure at 5 minutes will result in the
subsequent patient to have an exposure time of 6 minutes, while a success at 5 minutes
will result in the subsequent patient to have an exposure time of 4 minutes. The patients
in the exposure arm will all listen to Mozart music played for them from a speaker that
will be controlled by the investigator. The study will terminate once the investigators
achieve 6 "cross overs" between up and down steps or if 30 participants have been
recruited-whichever comes first. Statistical analysis and final ED50 determination will
be done using methods described by Dixon and Massey.