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Pre-operative Stress Reduction With Music

Not Applicable
Active, not recruiting
Conditions
Pediatric Pre-operative Stress
Interventions
Other: Relaxing Music
Other: No Music
Registration Number
NCT02870517
Lead Sponsor
Milton S. Hershey Medical Center
Brief Summary

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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
212
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Relaxing MusicRelaxing MusicParticipants will listen to relaxing music through noise-cancelling headphones during induction.
No MusicNo MusicParticipants will wear noise-cancelling headphones during induction but no music will be played through them.
Primary Outcome Measures
NameTimeMethod
Change in Heart Rate from baseline recorded when the headphones are placed on the patient15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
Secondary Outcome Measures
NameTimeMethod
Change in Respiratory Rate from baseline recorded when the headphones are placed on the patient15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
Change in Blood Pressure from baseline recorded when the headphones are placed on the patient15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation

Trial Locations

Locations (1)

Penn State Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

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