Protocol summary

Summary
Introduction: The goal of this research was studying the effect of music therapy on ventilatory criteria of patients under mechanical ventilation hospitalized in special wards and using music therapy as a complementary medicine. Complications of patients under mechanical ventilation are so much and considerable. One of the factors by recovery of which the separation from ventilator take place is ventilation criteria. Nursing, using music therapy, in case of reducing stress and anxiety, can cause ventilatory criteria and wening from mechanical ventilation tool. Materials and Methods: The present research took place with two group clinical trial method in intensive care unit of Hazrat Rasoul Akram Hospital. In this research 70 patients were chosen by random sampling methodology and divided in two 35-person intervention and control groups. For intervention group relaxing music therapy was played with headphone for 30 minutes once in the morning and once in the afternoon each day. For control group headphone was used without music in two turns each for 30 minutes. In both groups ventilation criteria of respiratory rate , peak airway pressure, minute ventilation, tidal volume and the amount of spo2 were recorded.

General information

Acronym
music and ventilation
IRCT registration information
IRCT registration number: IRCT201411304443N16
Registration date: 2015-05-07, 1394/02/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-07, 1394/02/17
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Music therapy on ventilation criteria of patients undergoing mechanical ventilation
Public title
music therapy and mechanical ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age above 18 and under 70 years, under respiratory support with ventilator and with modes of CPAP, PSV, SIMV, maximum number of mandatory breathing apparatus Was 10, Tracheal intubation or Tracheostomy, staying under mechanical ventilation for more than 24 hours, the Glasgow score above 7, the acute physiology score or APACHE II less than 20, no hearing problems, Hemodynamically stable condition including heart rate under 130 beats per minutes and systolic blood pressure above 90 mm Hg. Exclusion criteria: Having COPD and ARDS, discharge; sever hemodynamic impairment, the patient's unwillingness to participate in the study, the death of patient
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Office building of Tehran University of medical Science, Keshavarz St, Tehran.
City
tehran
Postal code
Approval date
2014-10-18, 1393/07/26
Ethics committee reference number
93/ص/130/1708

Health conditions studied

1

Description of health condition studied
patients undergoing mechanical ventilation
ICD-10 code
j95.0 , j9
ICD-10 code description
Chronic respiratory failure, Acute respiratory failure

Primary outcomes

1

Description
peak airway presser
Timepoint
30 minutes in morning and 30 minutes in evening
Method of measurement
Seen from the ventilator monitor and recorded in H2O cm

2

Description
tidal volume
Timepoint
30 minutes in morning and 30 minutes in evening
Method of measurement
Seen from the ventilator monitor and recorded in ml

3

Description
respiratory rate
Timepoint
30 minutes in morning and 30 minutes in evening
Method of measurement
Seen from the ventilator monitor and recorded in terms of the number per minute

4

Description
minute ventilation
Timepoint
30 minutes in morning and 30 minutes in evening
Method of measurement
Seen from the ventilator monitor and recorded in ml

5

Description
spo2
Timepoint
30 minutes in morning and 30 minutes in evening
Method of measurement
From pulse oximeter monitor in percentile

Secondary outcomes

1

Description
respiratori rate- spo2-peak airway presser-tv-mv
Timepoint
Time zero and ten and twenty and thirty minutes after the start of Music Therapy
Method of measurement
by using ventilator monitorig

Intervention groups

1

Description
In control group, the headphone was also used to prevent the annoying noises and patients were evaluated twice for one day that the duration of each one was 30 minutes between 9:30-10 AM and 16-16:30 PM. Restrictions imposed were same as intervention group. As the intervention group, all reparatory parameters and other variables were also measured in control group.
Category
Other

2

Description
In intervention group, instrumental music was played by headphone twice for one day that the duration of each one was 30 minutes between 9:30-10 AM and 16-16:30 PM. The music used in the study was track 1 of Arnd Stein's masterwork, namely Peace in Dream. This track is about 30 minutes. We chose the evening and morning to intervention, because of minimal medical interventions in these times. The researcher was present during the intervention. The respiratory parameters were recorded from the monitor at specified times. And during the study in intervention group, other nonemergency nursing interventions were stopped. The time for recording the respiratory parameters was defined as follows: before using the headphone and playing the music as 0, 10 minutes after playing music as 10, 20 minutes after playing music as 20, 30 minutes after playing music as 30; and all parameters were recorded from monitor of ventilator.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
rasol akram hospital
Full name of responsible person
masoomeh zakeri moghadam
Street address
Hazrat Rasoul Akram hospital,Niyayesh St, Sattarkhan St, Tehran.
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
masume zakeri moghadam
Street address
tohid square
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
masoome zakeri moghadam
Position
board of scientific
Other areas of specialty/work
Street address
Tehran University Of medical Science, School of Nursing and Midwifery, Nosrat St, Tohid Sq, Tehran.
City
tehran
Postal code
Phone
+98 61054343
Fax
Email
mzakerimo@gmail,com
Web page address
www.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
masoome zakeri moghadam
Position
bord of scientific
Other areas of specialty/work
Street address
Tehran University Of medical Science, School of Nursing and Midwifery, Nosrat St, Tohid Sq, Tehran.
City
tehran
Postal code
iran
Phone
+98 61054343
Fax
Email
mzakerimo@gmail.com
Web page address
www.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
hosein bahadori far
Position
critical care nursing student
Other areas of specialty/work
Street address
Hazrat Rasoul Akram hospital,Niyayesh St, Sattarkhan St, Tehran.
City
tehran
Postal code
Phone
+98 61054343
Fax
Email
hoseinbahadorifar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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