Effect of a Music Therapy Intervention on Mood

Critically Ill Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127344
• Other study ID #: IIBSP-MUS-2018-83
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Mª del Mar Vega Castosa
• Phone: +34.649.743.325
• Email: MVegaC[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 31, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patient

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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