Clinical trial NCT04127344: Effect of a Music Therapy Intervention on Mood
Official title: Effect of a Music Therapy Intervention on the Mood of the Critical Patient in a Tertiary Hospital.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Ill Patient
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial, parallel and open label.
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: 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

Primary outcomes:
measure: Mood state
timeFrame: 24 hours
Secondary outcomes:
measure: Level of pain
timeFrame: 24 hours
measure: Consumption of analgesics and sedatives
timeFrame: 24 hours
measure: Consumption of vasoactive drugs
timeFrame: 24 hours
measure: Physiological variables (blood pressure, heart rate, breathing rate and oxygen saturation)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Mª del Mar Vega Castosa
role: PRINCIPAL_INVESTIGATOR
References: