Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-31 @ 7:34 PM
Study NCT ID:
NCT05077306
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Receptive Music Therapy on Anxiety and Vital Parameters in Hospitalized Covid-19 Patients.
Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Organization:
Study Overview
Official Title:
Effect of Musical Listening on Anxiety and Depression in Patients Hospitalized for Covid-19: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MADC-19
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: