Receptive Music Therapy on Anxiety and Vital Parameters in Hospitalized Covid-19 Patients. (MADC-19)

October 12, 2021 updated by: Prof.Nicola Brienza, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Effect of Musical Listening on Anxiety and Depression in Patients Hospitalized for Covid-19: a Randomized Controlled Trial

Hospitalized patients for Covid-19 are extremely isolated from their families for a long and uncertain period of time .This traumatic separation makes patients vulnerable to different degrees of stress disorders as well as depression and anxiety , fear of the unknown and dying, sleeplessness, agitation, discomfort, pain, immobility, frustration and inability to relax .

MusicTtherapy has been shown to play a valuable role in the care of patients with serious illness, helping to address physical symptoms and psychological distress .

The aim of this study was to evaluate the feasibility of introducing Music therapy (MT) on site with Covid-19 patients as a supporting complementary/non-pharmacological intervention, to investigate the immediate effects a single MT session has on anxiety, heart rate (HR), oxygen saturation (O2Sat) and satisfaction compared to standard care.

In order to verify the hypotheses of the study, an RCT (mixed-methods approach pre -post design) will be carried out on patients diagnosed with SARS-COV2 admitted to Covid Hospital Bari, randomized into two groups: control group (B) and treatment group (A). .

The study starts on 15th April 2021 and it is expected to run for 1 mounth (15th May 2021).

The study is funding by University of Bari.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • AOUC Policlinico di Bari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 18 years
  • not severe neurological or psychiatric conditions
  • not hearing impairment
  • not intubated

Exclusion Criteria:

  • age under 18 years
  • severe neurological or psychiatric conditions
  • hearing impairment
  • intubated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: music therapy group
Patients receive an individual single session of receptive music therapy in presence.
Other: music therapy group
individual bedside single session of receptive music therapy (RMT) by a certified Music therapist- GIM fellow in presence. STAI Y-1 was administered 5 min. before session (STAI Y-1 PRE) and 15 min. after session (STAI Y-1 POST) in paper form. HR and O2Sat were recorded from the bedside monitor 3 times: start session (T0), 10 min. (T1), end session (T2).Participants i were asked to fill in an optional open-ended question concerning their experience with music therapy.
No Intervention: Control group
Patients receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Trait Anxiety Inventory Y-1
Time Frame: through study completion - an average of 30 days
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values <40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and> 59 severe anxiety
through study completion - an average of 30 days
State Trait Anxiety Inventory Y-1
Time Frame: through study completion- an average of 30 days
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values <40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and> 59 severe anxiety. T1-during session.
through study completion- an average of 30 days
State Trait Anxiety Inventory Y-1
Time Frame: through study completion - an average of 30 days
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values <40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and> 59 severe anxiety. T2- end session
through study completion - an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Investigators

  • Principal Investigator: Nicola Brienza, Phd, University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID.MT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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