AzTrials
AzTrials

Stress, PsychologicalNCT05980429

Sleep & Stress in Healthcare Providers After Defined Music Intervention Measure by 7-Tesla fMRI & Actigraphy

A study testing Music Therapy, prescribed and Music Therapy, self-selected in people with Stress, Psychological and Burnout, Professional, run by The Methodist Hospital Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study plans to explore whether specially chosen relaxing music can help improve sleep, reduce stress, and prevent burnout in healthcare workers, many of whom are often sleep-deprived. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
What is being tested?
Music Therapy, prescribed and Music Therapy, self-selected
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
1 Jun 2020to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

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 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • attending surgeon at Houston Methodist Hospital, Houston, Texas

Who cannot join

  • diagnosed sleep apnea
  • hearing impairment
  • cognitive impairment
  • large metal implants
  • Self-reported regular use of prescribed sleep medications

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Houston Methodist Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Neurophysiological Impact of Prescribed and Self-selected Music Intervention on Stress, Burnout, and Sleep in Surgeons-a 7-Tesla fMRI and Actigraphy Randomized Controlled Pilot Study

This study plans to explore whether specially chosen relaxing music can help improve sleep, reduce stress, and prevent burnout in healthcare workers, many of whom are often sleep-deprived. The researchers will measure changes in brain activity, sleep patterns, and self-reported stress levels before, during, and after participants listen to this music. The novel approach includes using advanced brain scanning technology, sleep monitoring devices, and carefully selected music. Ultimately, the aim is to create a scientifically backed music intervention that can be used widely to help healthcare providers get better sleep and manage stress, potentially reducing burnout rates.

Read the detailed description

Study Summary Sleep deprivation is a serious safety hazard in acute-stress, high-autonomy, high-immediacy, and high-risk work environments, where small errors in judgment or motor performance can deleteriously impact clinical performance and patient outcomes. A reported 65% of acute-care physicians suffer from acute and chronic sleep deprivation, and 50-70% of emergency-care physicians have reported symptoms of burnout. Sleep-deprived surgeons performed surgical tasks less competently and more slowly than intoxicated surgeons. Prior functional magnetic resonance imaging (fMRI) studies have linked sleep deprivation to an impaired ability to down-regulate negative emotions. Music serves as an effective and powerful modulator of human stress responses, effectively alleviating psychophysiological stress, enhancing functional connectivity in the emotional centers in the brain, and improving sleep by dynamically modulating the hypothalamic-pituitary-adrenal (HPA) axis, autonomic nervous system (ANS) and heart rate variability (HRV).

The central hypothesis is that listening to validated stress-reducing music containing defined compositional elements of relaxation will enhance sleep quality and/or quantity, reduce self-reported psychological stress, and mitigate burnout in health care providers. The study aims to test this hypothesis by measuring pre-, intra-, and post- intervention changes in brain activation, functional connectivity, and neurotransmitter releases using 7-Tesla fMRI; in qualitative and quantitative sleep patterns using clinically validated actigraphy straps; and in self-reported psychological stress and burnout using validated surveys. The study will provide essential data for a formal intervention to improve bedtime routines among healthcare providers prone to acute and chronic stress, sleep deprivation, depression and burnout.

The novelty of the proposed study is threefold: (1) use of high-resolution 7-Tesla fMRI technology to visualize neurological changes in the brain during and after the defined music intervention; (2) use of state-of-the-art actigraphy to qualitatively and quantitatively measure music-induced changes in slow wave and rapid eye movement (REM) sleep; and (3) use of sophisticated and precise repertoire-selection methodology developed by expert musicians on the team and aimed at increasing the reproducibility and scientific rigor in future music intervention studies. Gathering the team's interdisciplinary expertise of concert musicians, a Grammy Award-nominated composer, acute-care physicians, surgeons, and sleep experts at Houston Methodist Hospital, the investigators seek to measure the impact of defined musical intervention on sleep, stress and burnout using repertoire ranging from the Baroque period to 21st Century and containing a combination of 16 universal Compositional Elements of Relaxation previously extracted and evaluated by the team.

The long-term goal is to implement and disseminate defined and scientifically reproducible stress-reducing and sleep-enhancing music interventions at the clinic and policy level that may alleviate psychophysiological stress and reduce the severity and prevalence of sleep deprivation and burnout in health care providers.

Purpose of the Study / Objectives

Objective 1 To measure the impact of defined music intervention on quality and quantity of sleep in acute care surgeons using WHOOP-a clinically validated actigraphy device The research objective is to evaluate both pre- and self-selected music interventions prior to bedtime as a low-cost, zero-risk, noninvasive, easy-to-implement, and non-pharmacological technique to enhance sleep qualitatively and quantitatively in acute care attendings, fellows, and residents as measured by clinically validated actigraphy strap (WHOOP).

Objective 2 To validate music-induced stress-reduction and emotion-regulating improvement via increased frontal-amygdala connection and using 7-Tesla fMRI The investigators seek to investigate neural mechanisms underlying impaired emotional regulation as a result of sleep deprivation, and to develop a better understanding of the effects of music intervention on the human stress response. An algorithm for the graph-theoretical analysis of functional magnetic resonance imaging (fMRI) data will be developed. Emotional centers including the amygdala and bilateral insula activation patterns will be visualized. The impact of music on the frontal lobe-amygdala connection will be examined. Network clustering analysis will be performed to evaluate functional subunits with highest interactions induced by music exposure. 7-Tesla fMRI in connection with graph theoretical network analysis will be used to identify and differentiate functional subunits in the human brain when under prescribed and self-selected music intervention.

Objective 3 To evaluate the impact of defined music intervention on self-reported psychological stress, quality of sleep and burnout in acute-care surgeons using validated surveys

The objective is to measure the impact of defined music intervention on self-reported psychological stress using the State-Trait Anxiety Inventory (STAI), on quality and quantity of sleep using the Pittsburgh Sleep Quality Index (PSQI), and on self-reported burnout syndrome using the Maslach Burnout Inventory (MBI). The study also aims to examine potential differences between the self-selected music and pre-selected music groups, and test the hypothesis that pre-selected music repertoire containing defined compositional elements of relaxation will achieve comparable or superior results at enhancing sleep and reducing self-reported stress. Additionally, a Brief Musical Experience Questionnaire (BMEQ) will be collected as information for the participants' musical background to investigate potential link between susceptibility to music intervention and prior musical training, preference and exposure.

Being tested
Music Therapy, prescribed, Music Therapy, self-selected
Keywords
Stress, Burnout, fMRI, Sleep, Deprivation, Music, Therapy
Medical subject headings
Stress, Psychological, Burnout, Professional, Sleep Deprivation, Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music Therapy, prescribedOther

    All music pieces selected for the prescribed intervention contain compositional elements of relaxation analyzed, prepared, and recorded by professional concert artists and a Grammy-nominated composer. The compositional elements included Accentuation, Articulation, Dynamic Range, Familiarity, Interpretive Expertise, Melodic Shape, Meter, Recording Quality, Repetition, Register, Rubato, Tempo, Texture, Timbre, Transition, and Tonality. These 15 repertoire-selecting parameters were used to choose the prescribed music play list for this study. Music used for the study was downloaded from a password-protected Google Drive accessible to the study participants assigned to the "prescribed music" intervention group.

  • Music Therapy, self-selectedOther

    All music pieces were self-selected by the participant

Study groups in NCT05980429
Study groupRoleWhat they receive
Music Therapy, PrescribedExperimentalDuring weeks 2-5, participants in the prescribed music group underwent a minimum of 15 minutes (mandatory) of nightly self-administered music intervention immediately before bedtime.
Receives: Other: Music Therapy, prescribed
Music Therapy, Self-selectedExperimentalDuring weeks 2-5, participants in the self-selected music group underwent a minimum of 15 minutes (mandatory) of nightly self-administered music intervention immediately before bedtime.
Receives: Other: Music Therapy, self-selected
No Music Therapy ControlNo interventionDuring weeks 2-5, participants in the no-music group continued as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in quantity of sleep (total sleep duration, hours)

    Hours of sleep recorded by the WHOOP device pre to post intervention

    Measured: 6 weeks

  2. Mean change in quality of sleep (light sleep duration, hours)

    Hours of light sleep recorded by the WHOOP device pre to post intervention

    Measured: 6 weeks

  3. Mean change in quality of sleep (rapid eye movement sleep duration, hours)

    Hours of rapid eye movement sleep recorded by the WHOOP device pre to post intervention

    Measured: 6 weeks

Secondary outcomes (4)
  1. Mean change in resting heart rate, beats per minute

    change in resting heart rate recorded by the WHOOP device pre to post intervention

    Measured: 6 weeks

  2. Mean change in heart rate variability root mean square of successive rate rhythm interval differences

    change in heart rate variability recorded by the WHOOP device pre to post intervention

    Measured: 6 weeks

  3. Mean change in response to Intensive Care Unit noise

    change in response assessed as functional connectivity in the insula region recorded by fMRI pre to post intervention

    Measured: 6 weeks

  4. Mean change in empathetic response

    change in response assessed as functional connectivity in the anterior cingulate region recorded by fMRI pre to post intervention

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start1 Jun 2020
  3. Primary completion30 Jun 2021
  4. Study completion31 Aug 2021

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were enrolled from the surgery staff at a quaternary care hospital after signing informed consent and were randomized using block randomization (1:1:1) to one of 3 groups: (1) 30 minutes of prescribed musical intervention at bedtime (PM), (2) 30 minutes of self-selected music listening at bedtime (PS), or (3) unaltered, normal bedtime routine, as a control (C).
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05980429
Sponsor's protocol ID
PRO00024163
Status last verified
Mar 2024
First submitted
18 Jul 2023
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McPherson T, Berger D, Alagapan S, Frohlich F. Active and Passive Rhythmic Music Therapy Interventions Differentially Modulate Sympathetic Autonomic Nervous System Activity. J Music Ther. 2019 Aug 13;56(3):240-264. doi: 10.1093/jmt/thz007.

    PubMed 31175814
  • Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

    PubMed 29034226
  • Nowak J, Dimitrov A, Oei NYL, Walter H, Adli M, Veer IM. Association of naturally occurring sleep loss with reduced amygdala resting-state functional connectivity following psychosocial stress. Psychoneuroendocrinology. 2020 Apr;114:104585. doi: 10.1016/j.psyneuen.2020.104585. Epub 2020 Jan 24.

    PubMed 32018119
  • Strine TW, Chapman DP. Associations of frequent sleep insufficiency with health-related quality of life and health behaviors. Sleep Med. 2005 Jan;6(1):23-7. doi: 10.1016/j.sleep.2004.06.003.

    PubMed 15680291
  • Oskrochi Y, Maruthappu M, Henriksson M, Davies AH, Shalhoub J. Beyond the body: A systematic review of the nonphysical effects of a surgical career. Surgery. 2016 Feb;159(2):650-64. doi: 10.1016/j.surg.2015.08.017. Epub 2015 Oct 1.

    PubMed 26431813
  • Dyrbye LN, West CP, Satele D, Boone S, Tan L, Sloan J, Shanafelt TD. Burnout among U.S. medical students, residents, and early career physicians relative to the general U.S. population. Acad Med. 2014 Mar;89(3):443-51. doi: 10.1097/ACM.0000000000000134.

    PubMed 24448053
  • Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.

    PubMed 22911330
  • Deneva T, Ianakiev Y, Keskinova D. Burnout Syndrome in Physicians-Psychological Assessment and Biomarker Research. Medicina (Kaunas). 2019 May 24;55(5):209. doi: 10.3390/medicina55050209.

    PubMed 31137738
  • Jackson-Koku G, Grime P. Emotion regulation and burnout in doctors: a systematic review. Occup Med (Lond). 2019 Feb 7;69(1):9-21. doi: 10.1093/occmed/kqz004.

    PubMed 30753715
  • Zentner M, Grandjean D, Scherer KR. Emotions evoked by the sound of music: characterization, classification, and measurement. Emotion. 2008 Aug;8(4):494-521. doi: 10.1037/1528-3542.8.4.494.

    PubMed 18729581
  • Rui M, Brandt A, Moore L, Hsu E, Karmonik C, Verma A, Valdivia Y Alvarado M, Frazier JT, Dhala A. Impact of Prescribed and Self-Selected Music Interventions on Stress, Sleep, Heart Rate Variability, and Brain Connectivity in Surgeons Using 7-Tesla Functional Magnetic Resonance Imaging and Wearable Actigraphy: Multimodal Feasibility Randomized Controlled Trial. JMIR Form Res. 2026 Apr 17;10:e84899. doi: 10.2196/84899.

    PubMed 42061859

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy, prescribed and Music Therapy, self-selected in people with Stress, Psychological and Burnout, Professional, run by The Methodist Hospital Research Institute 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 15 Mar 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean change in quantity of sleep (total sleep duration, hours) (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT05980429, which also lists 11 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 15 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in