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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05077306
Acronym
MADC-19
Enrollment
40
Registered
2021-10-14
Start date
2021-04-15
Completion date
2021-06-30
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV2 Infection

Keywords

music therapy, anxiety, stress, quality of life, vital parameters

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.

Interventions

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.

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
State Trait Anxiety Inventory Y-1through study completion - an average of 30 daysState 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026