Pediatric Pre-operative StressNCT02870517
Pre-operative Stress Reduction With Music
A study testing Relaxing Music and No Music in people with Pediatric Pre-operative Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Pediatric Pre-operative Stress
- What is being tested?
- Relaxing Music and No Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Hearing impairments or ear abnormalities
- Pre-existing issues with substance abuse, anxiety, or depression
- Pre-existing psychiatric disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: The Effect of Music on Pre-operative Stress in Pediatric Orthopedic Patients
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.
Read the 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.
- Conditions
- Pediatric Pre-operative Stress
- Being tested
- Relaxing Music, No Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxing MusicOther
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 MusicOther
The patient will wear noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.
| Study group | Role | What they receive |
|---|---|---|
| Relaxing Music | Experimental | Participants will listen to relaxing music through noise-cancelling headphones during induction. Receives: Other: Relaxing Music |
| No Music | Active comparator | Participants will wear noise-cancelling headphones during induction but no music will be played through them. Receives: Other: No Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate from baseline recorded when the headphones are placed on the patient
Measured: 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
Measured: 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
Measured: 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric Pre-operative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Barbieri, Milton S. Hershey Medical Center
- Investigators
- Carolyn Barbieri, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870517
- Sponsor's protocol ID
- STUDY00005361
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2016
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 3043570Oral 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.
PubMed 26460523Daniel 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.
PubMed 26850800Bradt 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.
PubMed 23740695
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Pre-operative Stress in Pediatric Orthopedic Patients
- ClinicalTrials.gov ID
- NCT02870517
- Acronym / sponsor ID
- STUDY00005361
- Conditions
- Pediatric Pre-operative Stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxing Music | Experimental | Other: Relaxing MusicParticipants will listen to relaxing music through noise-cancelling headphones during induction. |
| No Music | Active comparator | Other: No MusicParticipants will wear noise-cancelling headphones during induction but no music will be played through them. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Hearing impairments or ear abnormalities
- Pre-existing issues with substance abuse, anxiety, or depression
- Pre-existing psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxing MusicRelaxing 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. | Other | Relaxing Music |
| No MusicThe patient will wear noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation. | Other | No Music |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 3043570Holden-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.
- Background: PubMed 26460523Oral 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.
- Background: PubMed 26850800Daniel 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.
- Background: PubMed 23740695Bradt 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.
- Individual participant dataSharing planned: No
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Adenotonsillectomy, Preoperative Anxiety
Recruiting
Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Barbieri, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxing Music and No Music in people with Pediatric Pre-operative Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02870517, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.