Effect of a Music Therapy Intervention on Mood

Study Overview
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Brief Summary
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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
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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)

Official Title
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Effect of a Music Therapy Intervention on the Mood of the Critical Patient in a Tertiary Hospital.

Conditions
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Critically Ill Patient

Intervention / Treatment
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* Behavioral: Music Therapy Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial, parallel and open label.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy Intervention<br>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. | Behavioral: Music Therapy Intervention<br>* 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.<br>|
| No Intervention: Non-Music Therapy Intervention<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 24 hours |