Effect of a Music Therapy Intervention on Mood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-12

Study Completion Date

2020-12-31

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.

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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)

Conditions

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Critically Ill Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial, parallel and open label.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music Therapy Intervention

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.

Group Type EXPERIMENTAL

Music Therapy Intervention

Intervention Type BEHAVIORAL

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.

Non-Music Therapy 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music 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.

Intervention Type BEHAVIORAL

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.