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

NCT02040051 | Completed DMC

• 1 other identifier: CEIC 13/36
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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)

Conditions

Intensive Care Units

Keywords

intensive care units; mechanical ventilation; music therapy

Outcome Measures

Primary Outcomes (3)

• Bispectral Index (BIS)

  Up to 4 hours

• Ramsay sedation scale

  Up to 4 hours

• Behaviour Pain Scale (BPS)

  Up to 4 hours

Secondary Outcomes (6)

• Blood pressure

  Up to 4 hours

• Heart rate

  Up to 4 hours

• Respiratory frequency

  Up to 4 hours

• Endotracheal aspirations

  Up to 4 hours

• Administration of sedatives drugs

  Up to 4 hours

Study Arms (2)

GROUP A: Sound isolation / Music therapy

ACTIVE COMPARATOR

* 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

GROUP B: Music therapy / Sound isolation

ACTIVE COMPARATOR

* 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

Interventions

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)

GROUP A: Sound isolation / Music therapy; GROUP B: Music therapy / Sound isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (1)

Fundació Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marina Mateu, BSc

  Althaia Xarxa Assistencial Universitària de Manresa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Bachelor

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 20, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

ES (1)