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NCT Number: NCT02870517

Pre-operative Stress Reduction With Music

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxing Music

Other

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.

no music

Other

The patient will wear noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2016
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.