Effect of a Music Therapy Intervention on Mood

NCT04127344 | Unknown

• 1 other identifier: IIBSP-MUS-2018-83
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill Patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Level of pain

  24 hours

• Consumption of analgesics and sedatives

  24 hours

• Consumption of vasoactive drugs

  24 hours

• Physiological variables (blood pressure, heart rate, breathing rate and oxygen saturation)

  24 hours

Study Arms (2)

Music Therapy Intervention

EXPERIMENTAL

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

Non-Music Therapy Intervention

NO 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.

Interventions

Music Therapy Intervention 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.

Music Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Auditory deficit
• Patients that have participated in the study previously

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Study Officials

• Mª del Mar Vega Castosa

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mª del Mar Vega Castosa

CONTACT

+34.649.743.325; MVegaC@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial, parallel and open label.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: October 15, 2019
• Study Start: March 12, 2019
• Primary Completion: March 12, 2020
• Study Completion: December 31, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

ES (1)