Effect of a Music Therapy Intervention on Mood

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

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.

Study Overview

• Status: Unknown
• Conditions: Critically Ill Patient
• Intervention / Treatment: Behavioral: Music Therapy Intervention

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)

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Mª del Mar Vega Castosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Mª del Mar Vega Castosa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Anticipated): March 12, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: IIBSP-MUS-2018-83

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No