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

Intensive Care Units Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040051
• Other study ID #: CEIC 13/36
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2021
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Units

Intervention

Behavioral:
• Sound 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)

Locations

Country	Name	City	State
Spain	Fundació Althaia Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Althaia Xarxa Assistencial Universitària de Manresa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bispectral Index (BIS)		Up to 4 hours
Primary	Ramsay sedation scale		Up to 4 hours
Primary	Behaviour Pain Scale (BPS)		Up to 4 hours
Secondary	Blood pressure		Up to 4 hours
Secondary	Heart rate		Up to 4 hours
Secondary	Respiratory frequency		Up to 4 hours
Secondary	Endotracheal aspirations		Up to 4 hours
Secondary	Administration of sedatives drugs		Up to 4 hours
Secondary	Administration of vasodilator and vasoconstrictor drugs		Up to 4 hours