Effect of a Music Therapy Intervention on Mood

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

Status: Unknown

Conditions: Critically Ill Patient

Treatments: Behavioral: Music Therapy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04127344

IIBSP-MUS-2018-83

Details and patient eligibility

About

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.

Full 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)

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

164 participants in 2 patient groups

Music Therapy Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Music Therapy Intervention

Non-Music Therapy Intervention

No Intervention group

Description:

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.