NCT05980429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

July 18, 2023

Last Update Submit

March 12, 2024

Conditions

Keywords

StressBurnoutfMRISleepDeprivationMusicTherapy

Outcome Measures

Primary Outcomes (3)

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

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

    6 weeks

  • 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

  • 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 Outcomes (4)

  • Mean change in resting heart rate, beats per minute

    6 weeks

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

    6 weeks

  • Mean change in response to Intensive Care Unit noise

    6 weeks

  • Mean change in empathetic response

    6 weeks

Study Arms (3)

Music Therapy, Prescribed

EXPERIMENTAL

During 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.

Other: Music Therapy, prescribed

Music Therapy, Self-selected

EXPERIMENTAL

During 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.

Other: Music Therapy, self-selected

No Music Therapy Control

NO INTERVENTION

During weeks 2-5, participants in the no-music group continued as usual.

Interventions

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, Prescribed

All music pieces were self-selected by the participant

Music Therapy, Self-selected

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • attending surgeon at Houston Methodist Hospital, Houston, Texas

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (10)

  • 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.

    PMID: 31175814BACKGROUND
  • 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.

    PMID: 29034226BACKGROUND
  • 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.

    PMID: 32018119BACKGROUND
  • 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.

    PMID: 15680291BACKGROUND
  • 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.

    PMID: 26431813BACKGROUND
  • 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.

    PMID: 24448053BACKGROUND
  • 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.

    PMID: 22911330BACKGROUND
  • 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.

    PMID: 31137738BACKGROUND
  • 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.

    PMID: 30753715BACKGROUND
  • 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.

    PMID: 18729581BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalBurnout, ProfessionalSleep DeprivationBurnout, Psychological

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOccupational StressOccupational DiseasesDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Medicine in Clinical Surgery

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 8, 2023

Study Start

June 1, 2020

Primary Completion

June 30, 2021

Study Completion

August 31, 2021

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations