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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
SARS-CoV2 Infection

Intervention / Treatment
-----------------
* Other: music therapy group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: music therapy group<br>Patients receive an individual single session of receptive music therapy in presence. | Other: music therapy group<br>* 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.<br>|
| No Intervention: Control group<br>Patients receive standard care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State Trait Anxiety Inventory Y-1 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, music therapy, stress, quality of life, vital parameters