Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
212 participants
INTERVENTIONAL
2017-01-31
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Relaxing Music
Participants will listen to relaxing music through noise-cancelling headphones during induction.
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.
No Music
Participants will wear noise-cancelling headphones during induction but no music will be played through them.
No Music
The patient will wear noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.
Interventions
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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.
No Music
The patient will wear noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pre-existing issues with substance abuse, anxiety, or depression
* Pre-existing psychiatric disorders
10 Years
16 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Carolyn Barbieri
Assistant Professor
Principal Investigators
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Carolyn Barbieri, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Locations
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Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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STUDY00005361
Identifier Type: -
Identifier Source: org_study_id