Effects of selected music-therapy on anxiety severity quantity and some indicators physiological of patients acute respiratory failure covid-19 undergoing non-invasive mechanical ventilation
Effects of selected music-therapy on anxiety severity quantity and some indicators physiological of patients acute respiratory failure covid-19 undergoing non-invasive mechanical ventilation
Design
Clinical trial with parallel control group, randomized, single center trial, Sample size 90 people (3 groups of 30 people) .
Settings and conduct
Babol Rohani Hospital
Participants/Inclusion and exclusion criteria
Patients with acute respiratory failure with Covid-19; Connection to non-invasive mechanical ventilation using face or nose-mouth masks; Awareness to the extent that there is the ability to communicate and answer questions; Interested in listening to music; Stable hemodynamic status without the use of vasoactive drugs; 24 hours have passed since admission to the ICU; Positional anxiety score should be 40 and higher.
Intervention groups
Intervention group 1: For each patient under non-invasive mask ventilation, he chooses 5 types of non-verbal soothing music based on his taste and plays for 20 minutes in the evening, using a headphone when no intervention is performed. Before and after the music is over, the physiological condition and vital signs and severity of the situational anxiety are measured again.
Intervention group 2: For 20 minutes, a headphone is inserted when no care or treatment intervention is performed for the patient. but the player is turned off and nothing is played to the patient.
Control group: The same routine interventions are performed and no additional interventions are performed.
Main outcome variables
Illness severity; Duration of admission to the ICU; The severity of anxiety.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N69
Registration date:2021-11-29, 1400/09/08
Registration timing:prospective
Last update:2021-11-29, 1400/09/08
Update count:0
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2022-12-01, 1401/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of selected music-therapy on anxiety severity quantity and some indicators physiological of patients acute respiratory failure covid-19 undergoing non-invasive mechanical ventilation
Public title
Effects of selected music therapy on anxiety severity quantity of patients acute respiratory failure covid-19
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute respiratory failure with Covid-19
Connection to non-invasive mechanical ventilation using face or nose-mouth masks
Awareness to the extent that there is the ability to communicate and answer questions
Interested in listening to music.
Stable hemodynamic status without the use of vasoactive drugs
24 hours have passed since admission to the ICU.
Positional anxiety score should be 40 and higher.
Exclusion criteria:
Drug addiction
Existence of hearing impairment
Dangerous cardiac arrhythmia
Receive narcotics and sedatives 6 hours before the study
Existence of pain while studying
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in ABC, ACB, BAC, BCA, CAB, and CBA using three blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 30 units of 3 blocks will be selected so that we consider having 30 people in the group (A), 30 people in the group (B) and 30 people in the group (C). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.SEMUMS.REC.1400.121
Health conditions studied
1
Description of health condition studied
Coronavirus
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Illness severity
Timepoint
Before and after the intervention
Method of measurement
APACHE II disease severity classification system
2
Description
Duration of admission to the ICU
Timepoint
From the beginning of entry until discharge from the ICU
Method of measurement
Number of days in the ICU
3
Description
The severity of anxiety
Timepoint
Before and after the intervention
Method of measurement
Spielberger test anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: For each patient under non-invasive mask ventilation, he chooses 5 types of non-verbal soothing music based on his taste and plays for 20 minutes in the evening, using a headphone when no intervention is performed. Before and after the music is over, the physiological condition and vital signs and severity of the situational anxiety are measured again.
Category
Treatment - Devices
2
Description
Intervention group 2: For 20 minutes, a headphone is inserted when no care or treatment intervention is performed for the patient. but the player is turned off and nothing is played to the patient.
Category
Treatment - Devices
3
Description
Control group: The same routine interventions are performed and no additional interventions are performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani Hospital
Full name of responsible person
Mohammadreza Asgari
Street address
Rouhani Hospital, Ganj Afrooz St., University Square, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3223 8304
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available