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

Sponsor

Althaia Xarxa Assistencial Universitària de Manresa (Other)

Overall Status

Completed

CT.gov ID

NCT02040051

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Units	Behavioral: Sound isolation / Music therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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)

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

Outcome Measures

Primary Outcome Measures

Bispectral Index (BIS) [Up to 4 hours]
Ramsay sedation scale [Up to 4 hours]
Behaviour Pain Scale (BPS) [Up to 4 hours]

Secondary Outcome Measures

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]
Administration of vasodilator and vasoconstrictor drugs [Up to 4 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundació Althaia Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona	Spain	08243

Sponsors and Collaborators

Althaia Xarxa Assistencial Universitària de Manresa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marina Mateu-Capel, Nurse Bachelor, Althaia Xarxa Assistencial Universitària de Manresa

ClinicalTrials.gov Identifier:

NCT02040051

Other Study ID Numbers:

CEIC 13/36

First Posted:

Jan 20, 2014

Last Update Posted:

Jul 27, 2021

Last Verified:

Jul 1, 2021

Keywords provided by Marina Mateu-Capel, Nurse Bachelor, Althaia Xarxa Assistencial Universitària de Manresa

intensive care units

mechanical ventilation

music therapy

Study Results

No Results Posted as of Jul 27, 2021