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Efficacy of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit

Randomized Clinical Trial to Assess the Effect of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02040051
Enrollment
82
Registered
2014-01-20
Start date
2013-06-30
Completion date
2014-06-30
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Units

Keywords

intensive care units, mechanical ventilation, music therapy

Brief summary

The purpose of this study is to assess the effect of sound insulation and music therapy on the comfort of mechanically ventilated patients admitted to intensive care unit measured by the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)

Interventions

BEHAVIORALSound isolation / Music therapy

Sound isolation: we will used headphones Noise Candelling HI-FI Polk Audio UF 8000 Control Talk for sound isolation. Music therapy: we will used relaxing Zen music. Light Reiki Touch (Album: Merlin's Magic; Composer: Andreas Mock. Published in 1995 by Inner Worl Music)

Sponsors

Althaia Xarxa Assistencial Universitària de Manresa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients of both sexes * Patients over 18 years old * Patients with a level of consciousness BIS ≥ 50

Exclusion criteria

* Patients with withholding treatment * Patients with partial or complete reduction of hearing in one or both ears * Patients with altered mental states: psychosis, schizophrenia, paranoia, neurosis, etc. * Patients with acute disease of the central nervous system: stroke, coma, encephalopathic process, etc. * Patients with an axillary temperature \> 37.5º

Design outcomes

Primary

MeasureTime frame
Bispectral Index (BIS)Up to 4 hours
Ramsay sedation scaleUp to 4 hours
Behaviour Pain Scale (BPS)Up to 4 hours

Secondary

MeasureTime frame
Endotracheal aspirationsUp to 4 hours
Blood pressureUp to 4 hours
Administration of vasodilator and vasoconstrictor drugsUp to 4 hours
Administration of sedatives drugsUp to 4 hours
Heart rateUp to 4 hours
Respiratory frequencyUp to 4 hours

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026