Pre-operative Stress Reduction With Music

NCT02870517 | Active Not Recruiting

• 1 other identifier: STUDY00005361
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Pre-operative Stress

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate from baseline recorded when the headphones are placed on the patient

  15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation

Secondary Outcomes (2)

• Change in Blood Pressure from baseline recorded when the headphones are placed on the patient

  15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation

• Change in Respiratory Rate from baseline recorded when the headphones are placed on the patient

  15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation

Study Arms (2)

Relaxing Music

EXPERIMENTAL

Participants will listen to relaxing music through noise-cancelling headphones during induction.

Other: Relaxing Music

No Music

ACTIVE COMPARATOR

Participants will wear noise-cancelling headphones during induction but no music will be played through them.

Other: No Music

Interventions

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.

Relaxing Music

No Music OTHER

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

No Music

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Hearing impairments or ear abnormalities
• Pre-existing issues with substance abuse, anxiety, or depression
• Pre-existing psychiatric disorders

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (4)

• 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.

  PMID: 3043570 BACKGROUND

• 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.

  PMID: 26460523 BACKGROUND

• 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.

  PMID: 26850800 BACKGROUND

• 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.

  PMID: 23740695 BACKGROUND

Study Officials

• Carolyn Barbieri, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 17, 2016
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)