Critically Ill PatientNCT04127344
Effect of a Music Therapy Intervention on Mood
A study testing Music Therapy Intervention in people with Critically Ill Patient, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The hypothesis is that the music therapy intervention has a positive impact on the critical patients' mood as it has a reassuring effect that allows a connection with emotions, helps to communicate and affects the welfare of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patient
- What is being tested?
- Music Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2019to 31 Dec 2020
- 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 who are oriented in time, space and person
- Glasgow Coma Scale of 15 or 11+intubated
- Negative the Confusion Assessment Method for the ICU (CAM-ICU)
- Richmond Agitation-Sedation Scale of 0
- Patients who are at least conscious and oriented for 48 hours in the ICU.
Who cannot join
- Auditory deficit
- Patients that have participated in the study previously
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Mª del Mar Vega Castosa
About this study
Official title: Effect of a Music Therapy Intervention on the Mood of the Critical Patient in a Tertiary Hospital.
The hypothesis is that the music therapy intervention has a positive impact on the critical patients' mood as it has a reassuring effect that allows a connection with emotions, helps to communicate and affects the welfare of patients. It also reduces pain and the consumption of painkillers and sedatives, as well as vasoactive drugs in critical patients.
Read the detailed description
The aim of the study is to assess the effect of a personalised music therapy intervention with standard treatment on critical patients' mood compared to those who just receive the standard treatment. Moreover, the effect of the different interventions on pain and sedative, analgesic and vasoactive drugs will also be assessed.
This is a randomized, parallel and open clinical trial that will compare: a) a music therapy intervention combined with the standard care (experimental group), with b) standard care (control group), on critical patients admitted to the General, Cardiac and Coronary Intensive Care Unit of the Santa Creu I Sant Pau Hospital.
The expected number of patients expected to be included in this trial is 164. Patients will be included and randomized the day the music therapy intervention is to take place, once a week. Patients' mood will be assessed with a validated questionnaire in Spanish for adults, the POMS (Profile of Mood States) survey that consists of a self-report built on the basis of a multidimensional conception of mood and has a Likert 5-points type format (0 to 4)
- Conditions
- Critically Ill Patient
- Being tested
- Music Therapy Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapy InterventionBehavioural
Patients randomized to a music therapy intervention will receive an individualised music therapy intervention. The sessions will last 10-20 minutes and they will be done by music therapist and musician.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy Intervention | Experimental | Patients enrolled will be randomised between two arms: Music Therapy Intervention and Non-Music Therapy Intervention.
Patients randomised to a music therapy intervention will receive an individualised music therapy intervention. Receives: Behavioral: Music Therapy Intervention |
| Non-Music Therapy Intervention | No intervention | Patients enrolled will be randomised between two arms: Music Therapy Intervention and Non-Music Therapy Intervention. Patients allocated to Non-Music Therapy Intervention received standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood state
The mood state will be assessed through the Profile of Mood States Scale (POMS) after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
Measured: 24 hours
Secondary outcomes (4)
Level of pain
The level of pain will be assessed through an Analogical Visual Scale after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
Measured: 24 hours
Consumption of analgesics and sedatives
Consumption of analgesics and sedatives will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
Measured: 24 hours
Consumption of vasoactive drugs
Consumption of vasoactive drugs will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
Measured: 24 hours
Physiological variables (blood pressure, heart rate, breathing rate and oxygen saturation)
The physiological variables will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start12 Mar 2019
- Primary completion12 Mar 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Randomized clinical trial, parallel and open label.
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mª del Mar Vega Castosa, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127344
- Sponsor's protocol ID
- IIBSP-MUS-2018-83
- Status last verified
- Mar 2020
- First submitted
- 29 Aug 2019
- Last updated
- 4 Mar 2020
- 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 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Music Therapy Intervention on the Mood of the Critical Patient in a Tertiary Hospital.
- ClinicalTrials.gov ID
- NCT04127344
- Acronym / sponsor ID
- IIBSP-MUS-2018-83
- Conditions
- Critically Ill Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 12 Mar 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Oct 2019 (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.
The hypothesis is that the music therapy intervention has a positive impact on the critical patients' mood as it has a reassuring effect that allows a connection with emotions, helps to communicate and affects the welfare of patients. It also reduces pain and the consumption of painkillers and sedatives, as well as vasoactive drugs in critical patients.
Detailed description
The aim of the study is to assess the effect of a personalised music therapy intervention with standard treatment on critical patients' mood compared to those who just receive the standard treatment. Moreover, the effect of the different interventions on pain and sedative, analgesic and vasoactive drugs will also be assessed.
This is a randomized, parallel and open clinical trial that will compare: a) a music therapy intervention combined with the standard care (experimental group), with b) standard care (control group), on critical patients admitted to the General, Cardiac and Coronary Intensive Care Unit of the Santa Creu I Sant Pau Hospital.
The expected number of patients expected to be included in this trial is 164. Patients will be included and randomized the day the music therapy intervention is to take place, once a week. Patients' mood will be assessed with a validated questionnaire in Spanish for adults, the POMS (Profile of Mood States) survey that consists of a self-report built on the basis of a multidimensional conception of mood and has a Likert 5-points type format (0 to 4)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial, parallel and open label.
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Intervention | Experimental | Behavioral: Music Therapy InterventionPatients enrolled will be randomised between two arms: Music Therapy Intervention and Non-Music Therapy Intervention. Patients randomised to a music therapy intervention will receive an individualised music therapy intervention. |
| Non-Music Therapy Intervention | No intervention | –Patients enrolled will be randomised between two arms: Music Therapy Intervention and Non-Music Therapy Intervention. Patients allocated to Non-Music Therapy Intervention received standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are oriented in time, space and person
- Glasgow Coma Scale of 15 or 11+intubated
- Negative the Confusion Assessment Method for the ICU (CAM-ICU)
- Richmond Agitation-Sedation Scale of 0
- Patients who are at least conscious and oriented for 48 hours in the ICU.
Key exclusion criteria (2 listed)
- Auditory deficit
- Patients that have participated in the study previously
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 randomized to a music therapy intervention will receive an individualised music therapy intervention. The sessions will last 10-20 minutes and they will be done by music therapist and musician. | Behavioural | Music Therapy Intervention |
Primary outcome
Mood state
Time frame: 24 hours
The mood state will be assessed through the Profile of Mood States Scale (POMS) after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
4 secondary outcomes
Level of pain
Time frame: 24 hours
Consumption of analgesics and sedatives
Time frame: 24 hours
Consumption of vasoactive drugs
Time frame: 24 hours
Physiological variables (blood pressure, heart rate, breathing rate and oxygen saturation)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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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.
Mª del Mar Vega Castosa principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site 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 Critically Ill Patient, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 5 inclusion and 2 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 4 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mª del Mar Vega Castosa (+34.649.743.325, MVegaC@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood state (time frame: 24 hours). 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 4 Mar 2020.