Receptive Music Therapy on Anxiety and Vital Parameters in Hospitalized Covid-19 Patients. (MADC-19)
Primary Purpose
SARS-CoV2 Infection
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
music therapy group
Sponsored by

About this trial
This is an interventional supportive care trial for SARS-CoV2 Infection focused on measuring music therapy, anxiety, stress, quality of life, vital parameters
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
Sites / Locations
- AOUC Policlinico di Bari
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
music therapy group
Control group
Arm Description
Patients receive an individual single session of receptive music therapy in presence.
Patients receive standard care
Outcomes
Primary Outcome Measures
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
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05077306
First Posted
October 8, 2021
Last Updated
October 12, 2021
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
1. Study Identification
Unique Protocol Identification Number
NCT05077306
Brief Title
Receptive Music Therapy on Anxiety and Vital Parameters in Hospitalized Covid-19 Patients.
Acronym
MADC-19
Official Title
Effect of Musical Listening on Anxiety and Depression in Patients Hospitalized for Covid-19: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection
Keywords
music therapy, anxiety, stress, quality of life, vital parameters
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music therapy group
Arm Type
Experimental
Arm Description
Patients receive an individual single session of receptive music therapy in presence.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients receive standard care
Intervention Type
Other
Intervention Name(s)
music therapy group
Intervention Description
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.
Primary Outcome Measure Information:
Title
State Trait Anxiety Inventory Y-1
Description
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
Time Frame
through study completion - an average of 30 days
Title
State Trait Anxiety Inventory Y-1
Description
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.
Time Frame
through study completion- an average of 30 days
Title
State Trait Anxiety Inventory Y-1
Description
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
Time Frame
through study completion - an average of 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Brienza, Phd
Organizational Affiliation
University of Bari
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOUC Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31104642
Citation
Fallek R, Corey K, Qamar A, Vernisie SN, Hoberman A, Selwyn PA, Fausto JA, Marcus P, Kvetan V, Lounsbury DW. Soothing the heart with music: A feasibility study of a bedside music therapy intervention for critically ill patients in an urban hospital setting. Palliat Support Care. 2020 Feb;18(1):47-54. doi: 10.1017/S1478951519000294.
Results Reference
background
PubMed Identifier
27481759
Citation
Mofredj A, Alaya S, Tassaioust K, Bahloul H, Mrabet A. Music therapy, a review of the potential therapeutic benefits for the critically ill. J Crit Care. 2016 Oct;35:195-9. doi: 10.1016/j.jcrc.2016.05.021. Epub 2016 May 28.
Results Reference
background
PubMed Identifier
31986257
Citation
Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available. Erratum In: Lancet. 2020 Jan 29;:
Results Reference
background
PubMed Identifier
23740695
Citation
Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
Results Reference
result
PubMed Identifier
35210504
Citation
Giordano F, Losurdo A, Quaranta VN, Campobasso N, Daleno A, Carpagnano E, Gesualdo L, Moschetta A, Brienza N. Effect of single session receptive music therapy on anxiety and vital parameters in hospitalized Covid-19 patients: a randomized controlled trial. Sci Rep. 2022 Feb 24;12(1):3154. doi: 10.1038/s41598-022-07085-8.
Results Reference
derived
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Receptive Music Therapy on Anxiety and Vital Parameters in Hospitalized Covid-19 Patients.
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