NCT04291677

Brief Summary

Patients admitted to the Intensive Care Units (ICU) that receive mechanical ventilation need high dose sedative and analgesic medication that may have side effects. Despite this, many of them also experience anxiety and added stress. Musical intervention is a useful non-pharmacological tool without adverse effects safe and easy to provide for patients with mechanical ventilation admitted to the Intensive Care Units. Its use reduces the use and dose of sedatives, reduces stress and environmental noise. It should be considered in the measures of control of anxiety and noise in the ICU. The objective of the study is to analyze whether the implementation of a musical intervention can be an effective non-pharmacological intervention in the therapy of patients undergoing mechanical ventilation admitted to an Intensive Care Unit of a High Complexity Hospital.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4.4 years

First QC Date

February 19, 2020

Last Update Submit

February 9, 2021

Conditions

Mechanical Ventilation

Keywords

Critical patientIntensive care unitMechanical ventilationSedative and analgesic medicationAnxietyLive musical intervention

Outcome Measures

Primary Outcomes (1)

  • Total and extra pseudoanalgesia requirements change.

    Change of the anxiety and pain level in patients with invasive mechanical ventilation with music therapy.

    It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.

Secondary Outcomes (9)

  • Change of Heart rate.

    It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.

  • Change of systolic blood pressure; diastolic blood pressure and mean blood pressure.

    It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.

  • Change vasoactive drug requirements.

    It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.

  • Blood glucose control.

    It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.

  • Change insulin requirements.

    It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.

  • +4 more secondary outcomes

Study Arms (2)

Intervention group in which musical intervention

EXPERIMENTAL

Group A: Experimental group in which musical intervention will be applied between the first and the third day of mechanical ventilation.

Other: intervention musical

Control group

OTHER

Group B: Control group with standard treatment without musical intervention.

Other: Without intervention musical

Interventions

intervention musicalOTHER

Intervention group in which musical intervention will be applied the first or third day of mechanical ventilation.

Intervention group in which musical intervention
Without intervention musicalOTHER

Control group with standard treatment without musical intervention.

Control group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients admitted to the ICU with requirements for mechanical ventilation and in which the unit's pseudoanalgesia protocol is implemented.
  • A legal representative informed consent to participate in the study has to be signed.

You may not qualify if:

  • Patients admitted to the ICU with predictable survival less than 48 hours.
  • Patients who are not subjected to mechanical ventilation.
  • Patients whose Legal representative refuses to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Juan Carlos Montejo, PhD MD

    Hospital Universitario 12 de Octubre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Intensive Care Medicine Service, MD, PhD

Study Record Dates

First Submitted

February 19, 2020

First Posted

March 2, 2020

Study Start

January 1, 2017

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)