Pre-operative Stress Reduction With Music

July 27, 2023 updated by: Carollyn Barbieri, Milton S. Hershey Medical Center

The Effect of Music on Pre-operative Stress in Pediatric Orthopedic Patients

The purpose of this study is to assess the effect of music, played prior to a surgical procedure, on stress levels during induction of anesthesia. Hypothesis: playing "calming" music, pre-selected by the investigator and the patient, beginning just prior to induction and terminating after induction will positively reduce the patient's heart rate, blood pressure, and respiratory rate during this period. For this study, noise-cancelling headphones with the ability to play music via an iPod will be utilized.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Reduced stress and relaxation positively contribute to patient healing after surgery (1). Reduction of stress associated with surgery is even more important in children, for whom a traumatic experience can have even more damaging and long-lasting effects (2). One stress-reduction technique of current interest is music. In global studies outside of the surgical realm, music has been shown to reduce heart rate, blood pressure, respiratory rate, and stress hormone levels as well as alleviate anxiety (3).

Evidence has also been found that listening to music pre-operatively in both adult and pediatric cases can reduce patients' stress and anxiety levels before surgery (3,7) Of the studies that have addressed the benefits of pre-operative music, however, none have assessed the impact of pre-operative music on stress levels during induction. In addition, almost all prior studies of the benefits of perioperative music have assessed the effect of only one style of music on each patient group. This set-up is beneficial in eliminating variables within the study design, but it fails to consider the individuality of each patient and what he/she might find to be relaxing. This study aims to assess the effect of music (selected by the pediatric patient from one of several pre-compiled playlists) played pre-operatively and during induction on patient stress levels.

Study Type

Interventional

Enrollment (Estimated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Hershey Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 10 - 16 years
  • Present to the OR for correction of an orthopedic complaint not involving the head or neck
  • Consent to participate in the study obtained from both the guardian and child
  • Patients and guardians are English-speaking

Exclusion Criteria:

  • Hearing impairments or ear abnormalities
  • Pre-existing issues with substance abuse, anxiety, or depression
  • Pre-existing psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relaxing Music
Participants will listen to relaxing music through noise-cancelling headphones during induction.
Other: Relaxing Music
Relaxing music, will be played through noise-cancelling headphones during induction of anesthesia. All of the songs used in this study will have <60 BPM, be instrumental rather than lyrical, and utilize predictable chord progressions. Music will be divided into several themed playlists which will be focused on the type of instruments involved including guitar, steel drum, and piano. The patient will listen to the music through noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.
Active Comparator: No Music
Participants will wear noise-cancelling headphones during induction but no music will be played through them.
Other: No Music
The patient will wear noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Heart Rate from baseline recorded when the headphones are placed on the patient
Time Frame: 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Blood Pressure from baseline recorded when the headphones are placed on the patient
Time Frame: 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
Change in Respiratory Rate from baseline recorded when the headphones are placed on the patient
Time Frame: 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Carolyn Barbieri, MD, Penn State College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimated)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00005361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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