Clinical trial NCT05077306: Receptive Music Therapy on Anxiety and Vital Parameters in Hospitalized Covid-19 Patients.
Official title: Effect of Musical Listening on Anxiety and Depression in Patients Hospitalized for Covid-19: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV2 Infection
Keywords: music therapy
anxiety
stress
quality of life
vital parameters
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: State Trait Anxiety Inventory Y-1
timeFrame: through study completion - an average of 30 days
measure: State Trait Anxiety Inventory Y-1
timeFrame: through study completion- an average of 30 days
measure: State Trait Anxiety Inventory Y-1
timeFrame: through study completion - an average of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUC Policlinico di Bari
Study officials:
affiliation: University of Bari
name: Nicola Brienza, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.