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Clinical Trials/NCT04127344
NCT04127344
Unknown
Not Applicable

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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country164 target enrollmentMarch 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critically Ill Patient
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
164
Locations
1
Primary Endpoint
Mood state
Last Updated
6 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
March 12, 2019
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

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

Outcomes

Primary Outcomes

Mood state

Time Frame: 24 hours

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 Outcomes

  • Consumption of vasoactive drugs(24 hours)
  • Consumption of analgesics and sedatives(24 hours)
  • Physiological variables (blood pressure, heart rate, breathing rate and oxygen saturation)(24 hours)
  • Level of pain(24 hours)

Study Sites (1)

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