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Pre-operative Stress Reduction With Music

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Penn State Health

Status

Active, not recruiting

Conditions

Pediatric Pre-operative Stress

Treatments

Other: Relaxing Music
Other: No Music

Study type

Interventional

Funder types

Other

Identifiers

NCT02870517
STUDY00005361

Details and patient eligibility

About

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.

Full 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.

Enrollment

212 estimated patients

Sex

All

Ages

10 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

212 participants in 2 patient groups

Relaxing Music
Experimental group
Description:
Participants will listen to relaxing music through noise-cancelling headphones during induction.
Treatment:
Other: Relaxing Music
No Music
Active Comparator group
Description:
Participants will wear noise-cancelling headphones during induction but no music will be played through them.
Treatment:
Other: No Music

Trial contacts and locations

1

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Central trial contact

Nancy R Jarbadan, BS; Carolyn Barbieri, MD

Data sourced from clinicaltrials.gov

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