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

NCT01669733 | Completed

• 1 other identifier: CASE5112
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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. 1.Patients in the live and recorded music groups will experience less anxiety than the non-music (standard care) group.
2. 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

Keywords

Breast Surgery; Breast Biopsy; Music Therapy

Outcome Measures

Primary Outcomes (2)

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

  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.

  at the time of surgery

• Change in anxiety levels

  Pre/posttests will be given using a Global Anxiety Visual Analog Scale (GA-VAS). A pretest will be given in the preoperative area before intervention and a posttest will be given after the live song, the recorded song, or five minutes of standard care has occurred. The investigators will measure the subject's marking (vertical line) on the GA-VAS from the left side of the GA-VAS to the subject's line using millimeters on a ruler.

  Pr- and post- music therapy prior to surgery

Secondary Outcomes (2)

• Amount of time in the PACU (post-anesthesia care unit)

  at time of discharge from PACU

• Patient satisfaction to music therapy

  at the time of PACU discharge

Study Arms (3)

Live/Recorded Music Group

EXPERIMENTAL

The music therapist will prepare a preferred song to be performed live in the preoperative room. Subjects in the live music group will listen to recorded music intraoperatively.

Other: Music

Recorded Music Group

EXPERIMENTAL

Recorded music group will be given an iPod and headphones and will listen to a recorded version of a preferred song.

Other: Music

No Music (Standard of care)

ACTIVE COMPARATOR

The control group will receive standard of care and no music.

Other: Standard of Care

Interventions

Music OTHER

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.

Also known as: Recorded Music, Live Music

Live/Recorded Music Group; Recorded Music Group

Standard of Care OTHER

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

No Music (Standard of care)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients with profound mental illness
• with developmental disability
• with significant hearing loss where music would not be heard from headphones
• currently taking narcotics

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44118, United States

Location

MeSH Terms

Interventions

Music Therapy; Standard of Care

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Deforia Lane, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 21, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

US (1)