Abnormal Breast Tissue Clinical Trial
Official title:
The Effects of Perioperative Music Therapy on Women Undergoing Breast Biopsy Surgery
The purpose of this research is to study the effect music has on women undergoing surgical
breast biopsy. Through the facilitation of live and/or recorded music listening, we will
examine the perception of patient anxiety, the total amount of propofol required to obtain a
BIS reading of 70, and recovery time in the PACU. We will also collect data and evaluate the
effect of live and/or recorded music on patient satisfaction. It is hypothesized that:
1. Patients in the live and recorded music groups will experience less anxiety than the
non-music (standard care) group.
2. Patients in the live and recorded music groups will experience a reduction in the
amount of anesthesia needed to reach a state of moderate sedation compared to the
non-music (standard care) group.
Music therapy's effect on anxiety in Preoperative.(live vs. recorded):
If the patient is randomly selected to the live music group, the music therapist will
prepare a preferred song to be performed live in the preoperative room. If the patient is
randomly selected for the recorded music group, she will be given an iPod and headphones and
will listen to a recorded version of her preferred song. If the patient is randomly selected
for the control group, she will receive standard care and no music. Pre/posttests will be
given using a Global Anxiety Visual Analog Scale (GA-VAS).
Music therapy's effect on propofol requirements intraoperatively:
Subjects in the live music group and subjects in the recorded music group will listen to
recorded music intraoperatively. All subjects will receive equal amounts of fentanyl and
versed. Subjects will receive fentanyl in the amount of 1 microgram per kilogram and versed
(midazolam) in the amount of 0.02 milligrams per kilogram from the nurse anesthetist. An
ipod with headphones will be given to the subject when she is being prepared to move to the
operating room. The board certified music therapist will initiate recorded music (harp
selections). Recorded music will be relaxing harp selections. The board certified music
therapist will accompany the subject to the operating room and assure volume levels and
electronic equipment function properly.
Anesthesia personnel will apply BIS monitor before propofol administration. Anesthesia
personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol
in micrograms per kilogram per minute, infusing at that point. Signal Quality Index (SQI)
will be recorded when the BIS reaches 70 to give credibility to the BIS monitor. SQI is a
measure of the signal quality for the EEG channel source and is calculated based on
impedance data, artifact, and other variables. The total amount of propofol for the case
will be recorded as total milligrams received. Anesthesia personnel will record Observer's
Assessment of the Alertness/Sedation (OAA/S) when BIS monitor reaches 70 or below as
incidental data point. A score of 3 on OAA/S indicates that the patient responds only after
mild prodding and shaking. OAA/S will be compared to BIS reading.
Time in PACU and Patient Satisfaction:
Recorded music will continue playing until the subject has met discharge criteria according
to University Hospital's policy and procedure. The amount of time between when the patient
leaves the operating room and meets discharge criteria (determined by nurse) will be
recorded. Patient satisfaction will be recorded using a Likert scale: 7= highly satisfied;
1=not at all satisfied after the subject has met her discharge criteria.
Controls: The control group subjects will receive standard anesthesia, nursing and surgical
care. All rating procedures will be the same. Controls will wear noise reducing headphones.
The music therapist will not accompany control patients following surgery. When the trial is
complete, the music therapist will offer the control subject a CD of the recorded music once
she has met discharge criteria and all data is recorded. This will occur for the sake of
ethics.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care