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

Not Applicable
Completed
Conditions
SARS-CoV2 Infection
Interventions
Other: music therapy group
Registration Number
NCT05077306
Lead Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
music therapy groupmusic therapy groupPatients receive an individual single session of receptive music therapy in presence.
Primary Outcome Measures
NameTimeMethod
State Trait Anxiety Inventory Y-1through 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

AOUC Policlinico di Bari

🇮🇹

Bari, Italy

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