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

Stress, Psychological Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05980429
• Other study ID #: PRO00024163
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2024
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• Music Therapy
• Sleep Deprivation
• Stress, Psychological

Intervention

Other:
• Music Therapy, prescribed
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-selected
All music pieces were self-selected by the participant

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Erratum In: Occup Med (Lond). 2019 Jun 24;69(4):304. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in quantity of sleep (total sleep duration, hours)	Hours of sleep recorded by the WHOOP device pre to post intervention	6 weeks
Primary	Mean change in quality of sleep (light sleep duration, hours)	Hours of light sleep recorded by the WHOOP device pre to post intervention	6 weeks
Primary	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	6 weeks
Secondary	Mean change in resting heart rate, beats per minute	change in resting heart rate recorded by the WHOOP device pre to post intervention	6 weeks
Secondary	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	6 weeks
Secondary	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	6 weeks
Secondary	Mean change in empathetic response	change in response assessed as functional connectivity in the anterior cingulate region recorded by fMRI pre to post intervention	6 weeks