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

NCT01669733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2015-08-24

No results posted yet for this study

Summary

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.

Conditions

  • Abnormal Breast Tissue

Interventions

OTHER

Music

Recorded or live music will be played prior to surgery in the preoperative room. Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively. 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.

OTHER

Standard of Care

The control group subjects will receive standard anesthesia, nursing and surgical care.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Deforia Lane, PhD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-07-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01669733 on ClinicalTrials.gov