Clinical trial NCT02870517: Pre-operative Stress Reduction With Music
Official title: The Effect of Music on Pre-operative Stress in Pediatric Orthopedic Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pediatric Pre-operative Stress
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 212
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Heart Rate from baseline recorded when the headphones are placed on the patient
timeFrame: 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
Secondary outcomes:
measure: Change in Blood Pressure from baseline recorded when the headphones are placed on the patient
timeFrame: 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
measure: Change in Respiratory Rate from baseline recorded when the headphones are placed on the patient
timeFrame: 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Carolyn Barbieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holden-Lund C. Effects of relaxation with guided imagery on surgical stress and wound healing. Res Nurs Health. 1988 Aug;11(4):235-44. doi: 10.1002/nur.4770110405.
citation: Oral R, Ramirez M, Coohey C, Nakada S, Walz A, Kuntz A, Benoit J, Peek-Asa C. Adverse childhood experiences and trauma informed care: the future of health care. Pediatr Res. 2016 Jan;79(1-2):227-33. doi: 10.1038/pr.2015.197. Epub 2015 Oct 13.
citation: Daniel E. Music used as anti-anxiety intervention for patients during outpatient procedures: A review of the literature. Complement Ther Clin Pract. 2016 Feb;22:21-3. doi: 10.1016/j.ctcp.2015.11.007. Epub 2015 Dec 1.
citation: Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.