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Completed

NCT Number: NCT02040051

Efficacy 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)

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Key information

Conditions

Intensive Care Units

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundació Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sound isolation / Music therapy

Behavioral

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)

Primary outcomes

  1. Bispectral Index (BIS)

    Time frame: Up to 4 hours

  2. Ramsay sedation scale

    Time frame: Up to 4 hours

  3. Behaviour Pain Scale (BPS)

    Time frame: Up to 4 hours

Secondary outcomes

  1. Blood pressure

    Time frame: Up to 4 hours

  2. Heart rate

    Time frame: Up to 4 hours

  3. Respiratory frequency

    Time frame: Up to 4 hours

  4. Endotracheal aspirations

    Time frame: Up to 4 hours

  5. Administration of sedatives drugs

    Time frame: Up to 4 hours

  6. Administration of vasodilator and vasoconstrictor drugs

    Time frame: Up to 4 hours

Sponsors and collaborators

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2014
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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