search
Back to results

Effect of a Music Therapy Intervention on Mood

Primary Purpose

Critically Ill Patient

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Music Therapy Intervention
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill Patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital de la Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Therapy Intervention

Non-Music Therapy Intervention

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 29, 2019
Last Updated
March 3, 2020
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
search

1. Study Identification

Unique Protocol Identification Number
NCT04127344
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patient

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial, parallel and open label.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Non-Music Therapy Intervention
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mood state
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Level of pain
Description
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.
Time Frame
24 hours
Title
Consumption of analgesics and sedatives
Description
Consumption of analgesics and sedatives will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
Time Frame
24 hours
Title
Consumption of vasoactive drugs
Description
Consumption of vasoactive drugs will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
Time Frame
24 hours
Title
Physiological variables (blood pressure, heart rate, breathing rate and oxygen saturation)
Description
The physiological variables will be assessed after randomization, within the next 6 to 12 hours, and 24 hours after randomization.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mª del Mar Vega Castosa
Phone
+34.649.743.325
Email
MVegaC@santpau.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª del Mar Vega Castosa
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mª del Mar Vega Castosa

12. IPD Sharing Statement

Learn more about this trial

Effect of a Music Therapy Intervention on Mood

We'll reach out to this number within 24 hrs