Clinical trial NCT05980429: Sleep & Stress in Healthcare Providers After Defined Music Intervention Measure by 7-Tesla fMRI & Actigraphy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Burnout, Professional
Sleep Deprivation
Music Therapy
Keywords: Stress
Burnout
fMRI
Sleep
Deprivation
Music
Therapy
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: OTHER

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

• attending surgeon at Houston Methodist Hospital, Houston, Texas

Exclusion Criteria:

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

Primary outcomes:
measure: Mean change in quantity of sleep (total sleep duration, hours)
timeFrame: 6 weeks
measure: Mean change in quality of sleep (light sleep duration, hours)
timeFrame: 6 weeks
measure: Mean change in quality of sleep (rapid eye movement sleep duration, hours)
timeFrame: 6 weeks
Secondary outcomes:
measure: Mean change in resting heart rate, beats per minute
timeFrame: 6 weeks
measure: Mean change in heart rate variability root mean square of successive rate rhythm interval differences
timeFrame: 6 weeks
measure: Mean change in response to Intensive Care Unit noise
timeFrame: 6 weeks
measure: Mean change in empathetic response
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References:
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