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The Effects of Perioperative Music Therapy on Women Undergoing Breast Biopsy Surgery


N/A
19 Years
N/A
Open (Enrolling)
Female
Abnormal Breast Tissue

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Trial Information

The Effects of Perioperative Music Therapy on Women Undergoing Breast Biopsy Surgery


Music therapy's effect on anxiety in Preop.(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.


Inclusion Criteria:



- Subjects who will undergo surgical breast biopsy under monitored anesthesia care

- English speaking women

- >18 years

- ASA classification of I (no systematic disease) or II (mild to moderate disease who
are medically stable) or III (severe systematic disease, not incapacitating)

Exclusion Criteria:

- Patients with profound mental illness

- with developmental disability

- with significant hearing loss where music would not be heard from headphones

- currently taking narcotics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

The cumulative intra-operative dose of propofol(mg) given to each patient

Outcome Description:

The primary outcome for this study will be the amount of propofol administered intra-operatively. Each of the groups receiving music pre-operatively and/or peri-operatively will be compared to the control (no music) group. Anesthesia personnel will apply BIS (Bispectral Index Monitor) 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. The total amount of propofol for the case will be recorded as total milligrams received.

Outcome Time Frame:

at the time of surgery

Safety Issue:

No

Principal Investigator

Deforia Lane, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE5112

NCT ID:

NCT01669733

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Abnormal Breast Tissue
  • Breast Surgery
  • Breast Biopsy
  • Music Therapy

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065