WeaningNCT04602182
Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation
A study testing music therapy intervention in people with Weaning and Respiration, Artificial, run by Basque Health Service at 2 sites in Spain.
Trial summary
1. OBJECTIVES: General objective: Assess the effects of a music therapy intervention during the weaning from the mechanical ventilation in a group of patients, and compare it to the usual clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Weaning, Respiration, Artificial, Music Therapy
- What is being tested?
- music therapy intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- 19 Oct 2020to 19 Jun 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on mechanical ventilation for at least 48 hours, with the decision to start the process of weaning, which comes determined by the decision to switch from controlled mode to support or spontaneous breathing modalities.
Who cannot join
- Patients with established moderate-severe psychiatric pathology.
- Patients with severe hearing deficit.
- Patients in whom the Limitation of Life Support Treatment (LTSV) has been decided and have a life expectancy of less than 48h.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Araba university hospital
Vitoria-Gasteiz, Alava
ESTHER CORRAL, +34945007000, ESTHER.CORRALLOZANO@osakidetza.eus
- Not yet recruiting
Esther Corral
Vitoria-Gasteiz, Alava
ESTHER CORRAL, ESTHER.CORRALLOZANO@osakidetza.eus
About this study
Official title: EFFECTS OF AN INTERVENTION WITH MUSICOTHERAPY IN THE WEANING FROM MECHANICAL VENTILATION IN PATIENTS OF THE INTENSIVE MEDICINE UNIT OF THE ALAVA UNIVERSITY HOSPITAL
- OBJECTIVES: General objective: Assess the effects of a music therapy intervention during the weaning from the mechanical ventilation in a group of patients, and compare it to the usual clinical practice. Specific objectives: Main objective: assess the effect of a music therapy intervention on the length of the weaning in a group of critical patients, and compare it to a group of critical patients who receive the usual clinical practice. Secondary objectives:
- Compare the levels of sedo-analgesia required in critical patients receiving the music therapy intervention during the process of weaning versus the levels of sedo-analgesia required by the control group.
- Compare the Anxiety-agitation level in critical patients receiving the music therapy intervention during the process of weaning, versus the anxiety-agitation leved felt by the control group.
- Compare the level of pain in critical patients receiving the music therapy intervention during the weaning versus the level of the pain felt by the control group.
- Compare the level of delirium in critical patients receiving music therapy during the weaning versus the level of delirium of the control group.
- Compare heart and breath frequency, blood pressure and oxygen saturation in critical patients receiving music therapy during the mechanical ventilation extubation (weaning) process, versus the index of control group.
- Compare the stress perceived in critical patients receiving music therapy intervention during the mechanical extubation process, versus the level of the control group, which receives the usual medical care (without intervention with music therapy), 90 days after Inico of the process, Perceived the Stress Scale (PSS).
- Describe and analyze the experience by the patient of the intervention with music therapy the weaning process and the coping strategies possible for musicotherapeutic intervention, using a Semi-instructed interview that takes place at 90 days beginning the process.
- DESIGN: single blind clinical trial in parallel groups, single blind clinical trial.
- POPULATION of this study are patients who initiate weaning for ventilation mechanics.
Read the detailed description
Experimental group: Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation.
Control group: Patient will follow the usual clinical practice for the weaning from mecanichal ventilation.
- Conditions
- Weaning, Respiration, Artificial, Music Therapy
- Being tested
- music therapy intervention
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapy interventionProcedure or surgery
Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| music therapy gruop (experimental group) | Experimental | Experimental group: Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation. Receives: Procedure: music therapy intervention |
| control group | Active comparator | Control group: Patient will follow the usual clinical practice for the weaning from mecanichal ventilation to the end of the weaning. Receives: Procedure: music therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lenght of weaning from mechanical ventilation (hours)
Time in hours from the beginning to the end of the disconnection process
Measured: within 1 week
Secondary outcomes (10)
Sedoanalgesia average dosis
Measured: within 1 week (during the weaning)
Score on the Richmond Agitation scale-24 hours prior to the start of the study, and every eight hours during the study and at the end of the mechanic ventilation disconnection period
RASS scoring and interpretation should be based on the sedation protocol being used. For minimal sedation protocols (RASS -2 to 0), sedation should be modified or decreased for a RASS score of -3 or less.[3] Scores of 2 to 4 may indicate under-sedation. At minimum, the patient should be assessed for pain, delirium, and anxiety. In addition, other underlying causes of agitation should be investigated and treated as appropriate.
In select cases, a deep sedation protocol (RASS -4 and -5) may be used.[3] For scores of -3 or higher, sedation should be modified to achieve the desired range
Measured: within 1 week (during the weaning)
Score on the Confusion Assessment Method scale for Intensive Care Units (CAM-ICU) 24 hours prior to the start of the study, and every eight hours during the study and at the end of the mechanical ventilation disconnection period
Rate each symptom of delirium listed in the instrument as absent (0), mild (1), or marked (2), except acute onset or fluctuating course which was rated as absent (0) or present (1). The severity score is created by an additive summary of the ratings ranging from 0-7 (short form) and 0-19 (long form). Higher scores indicate more severe delirium.
Measured: within 1 week (during the weaning)
Systolic TA (mm hg) at the beginning, at the end of the intervention, and 30 minutes after the end
Measured: within 1 week (during the weaning)
Diastolic TA (mm hg) at the beginning, at the end of the operation, and 30 minutes after the end
Measured: within 1 week (during the weaning)
Heart rate (beats/minutes) at the beginning, at the end of the intervention, and 30 minutes after the end
Measured: within 1 week (during the weaning)
Breathing frequency at the beginning, at the end of the speech, and 30 minutes after the end
Measured: within 1 week (during the weaning)
Oxygen saturation, at the beginning, at the end of the intervention, and 30 minutes after the end
Measured: within 1 week (during the weaning)
Perceived Stress Scale (PSS) score
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceivedstress. ►Scores ranging from 0-13 would be considered low stress. ►Scores ranging from 14-26 would be considered moderate stress.►Scores ranging from 27-40 would be considered high perceived stress.
Measured: 90 days after the start of the weaning process
Perception of the influence of the Music Therapy Intervention and intervention strategies, through a Semi-structured Interview
Measured: 90 days after having started the process of disconnecting the mechanical ventilation (weaning)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start19 Oct 2020
- Primary completion19 Oct 2021
- Study completion19 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeaningStudies 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
- Parallel groups
- Model description
- Single-blind randomized clinical trial in parallel groups and controlled with standard clinical practice.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- AGRUPARTE S.L.
- Responsible party
- Principal investigator, Esther Corral Lozano, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602182
- Sponsor's protocol ID
- MusicoT
- Status last verified
- Dec 2021
- First submitted
- 20 Oct 2020
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF AN INTERVENTION WITH MUSICOTHERAPY IN THE WEANING FROM MECHANICAL VENTILATION IN PATIENTS OF THE INTENSIVE MEDICINE UNIT OF THE ALAVA UNIVERSITY HOSPITAL
- ClinicalTrials.gov ID
- NCT04602182
- Acronym / sponsor ID
- MusicoT
- Conditions
- Weaning, Respiration, Artificial, Music Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- AGRUPARTE S.L.
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Jun 2022 (estimated)
- First posted
- 26 Oct 2020 (actual)
- 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.
- OBJECTIVES: General objective: Assess the effects of a music therapy intervention during the weaning from the mechanical ventilation in a group of patients, and compare it to the usual clinical practice. Specific objectives: Main objective: assess the effect of a music therapy intervention on the length of the weaning in a group of critical patients, and compare it to a group of critical patients who receive the usual clinical practice. Secondary objectives:
- Compare the levels of sedo-analgesia required in critical patients receiving the music therapy intervention during the process of weaning versus the levels of sedo-analgesia required by the control group.
- Compare the Anxiety-agitation level in critical patients receiving the music therapy intervention during the process of weaning, versus the anxiety-agitation leved felt by the control group.
- Compare the level of pain in critical patients receiving the music therapy intervention during the weaning versus the level of the pain felt by the control group.
- Compare the level of delirium in critical patients receiving music therapy during the weaning versus the level of delirium of the control group.
- Compare heart and breath frequency, blood pressure and oxygen saturation in critical patients receiving music therapy during the mechanical ventilation extubation (weaning) process, versus the index of control group.
- Compare the stress perceived in critical patients receiving music therapy intervention during the mechanical extubation process, versus the level of the control group, which receives the usual medical care (without intervention with music therapy), 90 days after Inico of the process, Perceived the Stress Scale (PSS).
- Describe and analyze the experience by the patient of the intervention with music therapy the weaning process and the coping strategies possible for musicotherapeutic intervention, using a Semi-instructed interview that takes place at 90 days beginning the process.
- DESIGN: single blind clinical trial in parallel groups, single blind clinical trial.
- POPULATION of this study are patients who initiate weaning for ventilation mechanics.
Detailed description
Experimental group: Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation.
Control group: Patient will follow the usual clinical practice for the weaning from mecanichal ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind randomized clinical trial in parallel groups and controlled with standard clinical practice.
| Arm | Type | Receives |
|---|---|---|
| music therapy gruop (experimental group) | Experimental | Procedure: music therapy interventionExperimental group: Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation. |
| control group | Active comparator | Procedure: music therapy interventionControl group: Patient will follow the usual clinical practice for the weaning from mecanichal ventilation to the end of the weaning. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on mechanical ventilation for at least 48 hours, with the decision to start the process of weaning, which comes determined by the decision to switch from controlled mode to support or spontaneous breathing modalities.
Key exclusion criteria (3 listed)
- Patients with established moderate-severe psychiatric pathology.
- Patients with severe hearing deficit.
- Patients in whom the Limitation of Life Support Treatment (LTSV) has been decided and have a life expectancy of less than 48h.
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 |
|---|---|---|
| music therapy interventionPatients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation. | Procedure or surgery | control group, music therapy gruop (experimental group) |
Primary outcome
Lenght of weaning from mechanical ventilation (hours)
Time frame: within 1 week
Time in hours from the beginning to the end of the disconnection process
10 secondary outcomes
Sedoanalgesia average dosis
Time frame: within 1 week (during the weaning)
Score on the Richmond Agitation scale-24 hours prior to the start of the study, and every eight hours during the study and at the end of the mechanic ventilation disconnection period
Time frame: within 1 week (during the weaning)
Score on the Confusion Assessment Method scale for Intensive Care Units (CAM-ICU) 24 hours prior to the start of the study, and every eight hours during the study and at the end of the mechanical ventilation disconnection period
Time frame: within 1 week (during the weaning)
Systolic TA (mm hg) at the beginning, at the end of the intervention, and 30 minutes after the end
Time frame: within 1 week (during the weaning)
Diastolic TA (mm hg) at the beginning, at the end of the operation, and 30 minutes after the end
Time frame: within 1 week (during the weaning)
Heart rate (beats/minutes) at the beginning, at the end of the intervention, and 30 minutes after the end
Time frame: within 1 week (during the weaning)
Breathing frequency at the beginning, at the end of the speech, and 30 minutes after the end
Time frame: within 1 week (during the weaning)
Oxygen saturation, at the beginning, at the end of the intervention, and 30 minutes after the end
Time frame: within 1 week (during the weaning)
Perceived Stress Scale (PSS) score
Time frame: 90 days after the start of the weaning process
Perception of the influence of the Music Therapy Intervention and intervention strategies, through a Semi-structured Interview
Time frame: 90 days after having started the process of disconnecting the mechanical ventilation (weaning)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy intervention in people with Weaning and Respiration, Artificial, run by Basque Health Service at 2 sites 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lenght of weaning from mechanical ventilation (hours) (time frame: within 1 week). 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 Dec 2021.