The effect of music on the agitation on the basis of Richmond in intubated patients admitted to the Medical Intensive Care Unit(ICU)
Design
Determination of control group and the intervention by random allocation (simple randomization).For both groups, the headphones are placed for 20 minutes each day for 3 days.In the intervention group, music is played but not in the music control group.Richmond is evaluated before and after intervention in each group.At the end of the third day, the results are evaluated and compared
Settings and conduct
Patients admitted to the ICU in Shahid Rajaee Hospital who have criteria for entering the study are in the intervention group and ICU 2 in the control group.For both groups, the headphones are placed for 20 minutes each day for 3 days.In the intervention group,non word music approved by the association will be played but in the control group will not be played.Richmond is evaluated before and after intervention in each group.
Participants/Inclusion and exclusion criteria
Entry Criteria: Having a tracheal tube from entry or on the first day of hospitalization in the unit, mechanical ventilation, Age between 16 and 70 years, Informed consent;
Non-entry criteria: Psychological disorder, Hemodynamic disorders, Addiction, Deafness and hearing problems, The ability to communicate verbally
Intervention groups
For both intervention and control groups, the headphones are placed for 20 minutes each day for 3 days.In the intervention group,non word music approved by the association will be played but in the control group will not be played.Richmond is evaluated before and after intervention in each group.
Main outcome variables
Agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180918041060N1
Registration date:2019-05-19, 1398/02/29
Registration timing:retrospective
Last update:2019-05-19, 1398/02/29
Update count:0
Registration date
2019-05-19, 1398/02/29
Registrant information
Name
Narges Seyfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3460 0724
Email address
n.seyfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music on the agitation on the basis of Richmond in intubated patients admitted to the Medical ICU
Public title
Music in agitation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a tracheal tube from entry or on the first day of hospitalization in the unit
mechanical ventilation
Age between 16 and 70 years
Informed consent
Exclusion criteria:
Psychological disorder
Hemodynamic disorders
Addiction
Deafness and hearing problems
The ability to communicate verbally
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not 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
Ethics Committee of Alborz University of Medical Sciences and Health Services
Street address
safariyan estreet, 45 yards of Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2018-08-05, 1397/05/14
Ethics committee reference number
IR.ABZUMS.REC.1397.063
Health conditions studied
1
Description of health condition studied
Restlessness and agitation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
agitation
Timepoint
before and 20 minutes after intervention
Method of measurement
Richmond
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the headphones are placed for 20 minutes each day for 3 days and non word music approved by the association will be played.The Richmond scale is evaluated before and after intervention.