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

July 24, 2021 updated by: Marina Mateu-Capel, Althaia Xarxa Assistencial Universitària de Manresa

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Manresa, Barcelona, Spain, 08243
        • Fundacio Althaia Xarxa Assistencial Universitaria de Manresa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP A: Sound isolation / Music therapy
  • PREINTERVENTION: First hour. The patient will remain under the usual conditions of intensive care unit
  • INTERVENTION: Second hour. Sound isolation
  • INTERVENTION: Third hour. Music therapy
  • POSTINTERVENTION: Fourth hour. The patient will remain under the usual conditions of intensive care unit
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)
Active Comparator: GROUP B: Music therapy / Sound isolation
  • PREINTERVENTION: First hour. The patient will remain under the usual conditions of intensive care unit
  • INTERVENTION: Second hour. Music therapy
  • INTERVENTION: Third hour. Sound isolation
  • POSTINTERVENTION: Fourth hour. The patient will remain under the usual conditions of intensive care unit
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bispectral Index (BIS)
Time Frame: Up to 4 hours
Up to 4 hours
Ramsay sedation scale
Time Frame: Up to 4 hours
Up to 4 hours
Behaviour Pain Scale (BPS)
Time Frame: Up to 4 hours
Up to 4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: Up to 4 hours
Up to 4 hours
Heart rate
Time Frame: Up to 4 hours
Up to 4 hours
Respiratory frequency
Time Frame: Up to 4 hours
Up to 4 hours
Endotracheal aspirations
Time Frame: Up to 4 hours
Up to 4 hours
Administration of sedatives drugs
Time Frame: Up to 4 hours
Up to 4 hours
Administration of vasodilator and vasoconstrictor drugs
Time Frame: Up to 4 hours
Up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Investigators

  • Principal Investigator: Marina Mateu, BSc, Althaia Xarxa Assistencial Universitària de Manresa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 24, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEIC 13/36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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