Intensive Care UnitsNCT02040051
Efficacy of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit
A study testing Sound isolation / Music therapy in people with Intensive Care Units, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Units
- What is being tested?
- Sound isolation / Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes
- Patients over 18 years old
- Patients with a level of consciousness BIS ≥ 50
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
About this study
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
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
- Being tested
- Sound isolation / Music therapy
- Keywords
- intensive care units, mechanical ventilation, music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound isolation / Music therapyBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Sound isolation / Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bispectral Index (BIS)
Measured: Up to 4 hours
Ramsay sedation scale
Measured: Up to 4 hours
Behaviour Pain Scale (BPS)
Measured: Up to 4 hours
Secondary outcomes (6)
Blood pressure
Measured: Up to 4 hours
Heart rate
Measured: Up to 4 hours
Respiratory frequency
Measured: Up to 4 hours
Endotracheal aspirations
Measured: Up to 4 hours
Administration of sedatives drugs
Measured: Up to 4 hours
Administration of vasodilator and vasoconstrictor drugs
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Mateu-Capel, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Marina Mateu, BSc, Principal investigator, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040051
- Sponsor's protocol ID
- CEIC 13/36
- Status last verified
- Jul 2021
- First submitted
- 14 Jan 2014
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02040051
- Acronym / sponsor ID
- CEIC 13/36
- Conditions
- Intensive Care Units
- Keywords
- intensive care units, mechanical ventilation, music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A: Sound isolation / Music therapy | Active comparator | Behavioral: 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 |
| GROUP B: Music therapy / Sound isolation | Active comparator | Behavioral: Sound isolation / Music therapy* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes
- Patients over 18 years old
- Patients with a level of consciousness BIS ≥ 50
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound isolation / Music therapySound 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) | Behavioural | GROUP A: Sound isolation / Music therapy, GROUP B: Music therapy / Sound isolation |
Primary outcome
Bispectral Index (BIS)
Time frame: Up to 4 hours
Ramsay sedation scale
Time frame: Up to 4 hours
Behaviour Pain Scale (BPS)
Time frame: Up to 4 hours
6 secondary outcomes
Blood pressure
Time frame: Up to 4 hours
Heart rate
Time frame: Up to 4 hours
Respiratory frequency
Time frame: Up to 4 hours
Endotracheal aspirations
Time frame: Up to 4 hours
Administration of sedatives drugs
Time frame: Up to 4 hours
Administration of vasodilator and vasoconstrictor drugs
Time frame: Up to 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Mateu, BSc principal investigator
Althaia Xarxa Assistencial Universitària de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound isolation / Music therapy in people with Intensive Care Units, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bispectral Index (BIS) (time frame: Up to 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.