Critically Ill Patient
Conditions
Brief 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. 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)
Interventions
BEHAVIORALMusic Therapy Intervention
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.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized clinical trial, parallel and open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Auditory deficit * Patients that have participated in the study previously
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mood state | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of pain | 24 hours | 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. |
| Consumption of analgesics and sedatives | 24 hours | Consumption of analgesics and sedatives will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization. |
| Consumption of vasoactive drugs | 24 hours | Consumption of vasoactive drugs will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization. |
| Physiological variables (blood pressure, heart rate, breathing rate and oxygen saturation) | 24 hours | The physiological variables will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization. |
Countries
Spain
Contacts
Primary ContactMª del Mar Vega Castosa
Outcome results
None listed