Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03280329 |
| Other study ID # |
Musicoterapia |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2017 |
| Est. completion date |
December 1, 2018 |
Study information
| Verified date |
June 2018 |
| Source |
University of Milan |
| Contact |
michele umbrello, MD |
| Phone |
+390281844476 |
| Email |
micheleumbrello[@]yahoo.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Admission to an Intensive Care Unit (ICU) is one of the major causes of stress and both
physical and emotional difficulties for critically ill patients, both because of the illness
that caused the admission and of the ICU nevironment itself. Despite the use of protocols and
tools to evaluate sedation, many patients continue to have high levels of anxiety. An
inadequate treatment of this condition is associated with increased sympathetic activity
which causes dyspnea and an increase in myocardial oxygen consumption. Sedative drugs, on the
other side, may have significant side effects.
In view of this, there is clear need to find new strategies and instruments allowing for the
maximization of critical patients' comfort, by promoting pain, anxiety, stress and agitation
relief and minimising the need of sedative therapy.
The main hypothesis of this study is that the use of music therapy for critically ill
patients can lead to a significant increase of the days free from neuroactive therapy
(analgesics, sedatives, antianxiety meds, antipsychotics) in the first 28 days following
Intensive Care Unit admission. To this purpose, data obtained from 3 groups of patients will
be compared - a group with individual treatment administered by a music therapist and
delivered by headphones, a group with a generalised treatment, through the creation of a
weekly musical program continuously broadcasted in the hospital room, and a control group.
Description:
Introduction The Intensive Care Unit (ICU) is one of the major causes of stress and both
physical and emotional difficulties for patients and their families.
Studies have been conducted in the investigators' and other Intensive Care Units and they set
out to investigate main causes of stress in critical patients; among the most significant
factors were shown to be life saving treatment such as mechanical ventilation, invasive
procedures, restriction of movement, pain and inability to verbally express it, environment
characterized by constant light and sound stimulation, loss of interaction with loved ones
and the staff, and sleep deprivation.
Despite the use of protocols and tools to evaluate sedation, many patients continue to have
high levels of anxiety. An inadequate treatment of this condition is associated with
increased sympathetic activity which causes dyspnea and an increase in myocardial oxygen
consumption.
In view of it, there is clear need to find new strategies and instruments allowing for the
maximization of critical patients' comfort, by promoting pain, anxiety, stress and agitation
relief and minimising the need of sedative therapy.
Among non pharmacological treatment, hypnosis and relaxation techniques, implementation of
communication with patient, music therapy and physical support are shown to be effective (7).
The use of music as a therapeutic complement has been described in literature for a long
time, using a rational selection in musical composition. Music application to obtain health
benefit is defined music therapy.
The main research question which this study aims to answers is music therapy's effectiveness
in reducing analgesics and sedatives need, as well as reducing anxiety and loneliness, and in
re- establishing normal sleep patterns. It should be noted that music brings significant
benefits as there is absence of contraindications and it is immediately usable by everybody.
Italian experiences in the music therapy field in the Intensive Care Unit are low.
With this music therapy project, the investigators intend to build a multifactorial
intervention to reduce stress risk factors of patients and their families, still not applied
in our country.
Rationale
Many factors influence the effectiveness by music therapy: age, gender, cognitive abilities,
stress levels, anxiety, pain, music education, familiarity with a determinate type of music,
individual preferences, and culture are all elements which can modify the effect of certain
music selection on the subject (19, 20). From this, there is the need of individual choice
and careful monitoring of effects that music has on each individual.
Music therapy in the treatment of stress in the Intensive Care Unit
A recent meta analysis (21) reveals that listening to music can cause a reduction of anxiety
levels in mechanically ventilated patients; some studies show, moreover, a reduction of
analgesic and sedative need in response to the application of a music therapy treatment.
Mechanisms underlying music therapy effectiveness A shared theory about the reduction of
anxiety induced by music is that it helps patients to distance their minds from environmental
stress factors to focus on pleasant sounds and calming incentives (8, 22).
The effect of music is extensive, moreover giving patients an aesthetic experience which
offers comfort and peace in a stressful situation. Guided interventions by music therapists
are more effective because music used is adapted to the needs of that determinate moment,
thanks to professional abilities. If music is selected personally by patient, this provides a
major sense of control in the environment, like that of Intensive Unit, where the patient is
almost totally dependent from health workers (23).
From the neuropsychological point of view, it was assumed that music has a relaxing effect
through its impact on central and autonomic nervous system (24- 26); more specifically, its
application determines a deleting effect on the sympathetic system, leading to a reduction of
circulating catecholamines and to lower nervous and muscle stimulation (25,27). Potential
benefits which result are reduction of pain, reduction of blood pressure, heart rate, oxygen
consumption and muscle tension (2).
Hypothesis of the study The hypothesis of this study is that the use of music therapy for
critically ill patients can lead to a significant increase of the days free from neuroactive
therapy (analgesics, sedatives, antianxiety meds, antipsychotics) in the first 28 days
following Intensive Care Unit admission, in absence of statistically significant reduction of
the welfare index of health workers.
All these data are not available in the literature and would represent an undiscussed
advantage in the promotion of welfare in critical patients during recovery in Intensive Care
and at distance from itself; this can also lead to possible significant implications in terms
of a more effective assistance and lower duration of the stay.
Purpose of the study
The present study study has the main purpose of verifying if using music therapy as an
individualised or generalized intervention in hospitalised patients in Intensive Care, in
different cure settings, allows for a reduction of total dose of
analgesics/sedatives/antipsychotics administered. The investigators will analyse if the
proposed intervention of music therapy can have a role in giving the following advantages:
- increased hours of sleep of patients,
- reduction of anxiety and psychomotor agitation manifestations,
- improvement of work welfare,
- lower grade of anxiety, stress, and post traumatic symptoms of the family,
- reduction of frequency and duration of physical restraint,
- practicability of the proposal of generalized music therapy, through the understanding
the frequency in which music is interrupted for reasons of clinical contingency.
To this purpose, data obtained from 3 groups of patients will be compared - a group with
individual treatment, a group with generalised treatment, through the creation of a weekly
musical program, and a control group.
The population in study will be that of patients hospitalised in Intensive Care for variable
aetiologies, which recovery is longer than 3 days.
All without undermine (or even improve) worker welfare, in order to improve physical and
psychological outcome of patients.
Protocol
Randomization and study groups
The 3 groups are:
1. Control: the patients who belong to this group will not be assigned to a regulated music
therapy treatment, thus they will listen to the background sounds (alerts, voices) right
in the Intensive Care environment; radio use will be allowed according to medical/
nursing judgements;
2. Personalised treatment: during a music therapy consultancy, each patient will be
investigated (if possible from the neurological point of view) on musical preferences
and list of possible music will be proposed which will be reproduced for 2 hours at day.
It is specified that this genre of intervention, as far as well described and studied in
literature, does not belong in clinical practice, and therefore earphones for listening
to music are not yet used in our task force.
3. Generalised treatment: it will be carried out through the creation of a 'weekly
playlist' with the following considerations:
1. Daily sound reproduction from 7 am to 11 pm, with 10 minutes break about every 50
minutes of music;
2. Spread through the environment with specifically designated speakers, at a
controlled volume (30-50 dB);
3. Choice of playlist of music both classic and modern, with very easy listening,
selected according to the daily hours to restore circadian rhythm and following
predictable activities of care provided to patients (hygienic care, retail food,
administration other therapies, physiotherapy, visit by relatives, …);
4. Mixing tracks so that there is continuity and fluidity of listening.
Patients will be randomly assigned to the study groups. On the basis that proposed
intervention has environmental nature (in control and music therapy group), patients
respecting inclusion and exclusion criteria to the protocol will be divided according to the
room occupied. The study is configured like a randomized study, not a blind one.
The environment where the study will take place, the departement of Anestesia e Rianimazione
of San Paolo Hospital - University, does not have single box but 3 open rooms, each one with
2 beds, in which single beds are separated by about 5 meters. This logistic issue will not
hinder the study execution since nothing changes with control group patients about sound
environmental management; for personalized music therapy group the use of earphones avoid the
music overlap coming from the other patients; equally for the generalized music therapy, in
view of intervention nature which provides passive exposure of patients to the music
reproduced in the whole environment of the room, the results will not be relatively impacted
by the ward. The 3 rooms are instead well disjoint among themselves, so that music coming
from one hardly can reach the others.
Collected data It will be measured for each patient's' free days from neuroactive drugs and
neuroactive drug total dosage administered. Moreover, the eventual need of use of restraints
for patient safety and duration will be registered.
Once per nursing shift, anxiety levels will be detected, measured with verbal scale number
(VNR), agitation, measured with RASS scale (Richmond Agitation- Sedation Scale), and pain
will be detected with VNR scale or behavioural measures (Behavioral Pain Scale, BPS).
Moreover the hours of sleep declared in medical record will be registered on the basis of
nurse evaluations.
Through semi structured interviews, welfare of the health care workers and relatives will be
investigated as well as the perceived interference of the intervention based on music
therapy; the impact of experience in Intensive Care on the lives of relatives will be
evaluated through a validated questionnaire (SSS- Short Scale for PTSS).
In order to verify the feasibility of the proposal of generalised music therapy, the number
of interruptions of music reproduction will be registered for contingent clinical reasons.
Analysis of data From the data collected, organised in a database in compliance with the
applicable privacy policy (law 196/2003), it will be possible to verify if the use of
personalised and generalised music therapy in patients hospitalized in Intensive Care, in
different care settings, allows for a reduction of total dosage of analgesic/ sedative/
antipsychotic drugs administered.
All the analysis will be centralised at the investigators' institution.
Sample size Assuming the possibility to transform data with Blom method, in order to obtain a
normal distribution and so higher power in equal amplitude sample, and assuming a effect size
of 0.30 and a doubling of the parameter of main outcome (days free from neuroactive drugs
administration) in the 2 groups of intervention compared to the control group, the sample
size required or an effective power of 80% is 53 subjects per group. This sample size is also
sufficient to cover the analysis conducted comparing measurements repeated on the same
patient. To this purpose, a linear model will be used which requires 51 subjects per groups,
assuming a correlation coefficient of 0.5 between measures and a size effect of 0.25. Sizing
was conducted with SAS software.
Statistical analysis Data will be expressed as median (standard deviation) if normally
distributed (Shapiro- Francia test), or like median ( range interquartile) otherwise. Data
will be transcribed from clinical records on a sheet of Microsoft Excel 2010 calculations
(Microsoft Corporation, Redmond, WA, USA). Statistical analysis will be performed with
Stata/SE 12.0 (StataCorp, College Station, TX USA). For each comparison statistical
significance will be considered for values of p<0.05.
