The purpose of this study was to investigate the effect of nature-based sounds’ intervention on agitation and anxiety in patients undergoing coronary artery bypass graft during the weaning of mechanical ventilation in intensive care units in Jamaran hospital in Tehran. This study is a randomized controlled trial, 120 patients undergoing coronary artery bypass graft during the weaning of mechanical ventilator were randomly assigned to the control and experimental groups. All participants were provided with information about the intervention. The patients in the experiment group were given nature-based sounds through an audiotape via fixed earphones. The patients assigned to the control group were asked to wear the foam-lined headphone and rest in silence for a similar time frame as the intervention group. The intensity of agitation and anxiety expressed by the participants in two groups were measured using the Richmond Agitation Sedation Scale (RASS) , Faces Anxiety Scale (FAS) and hemodynamic changes for ten times. In the intervention group, nature-based sounds will be played for 20 minutes intervals on according to patients’ preference but in the control group wear the foam-lined headphone without sounds. Before and then at intervals of 20 minutes applying technique the indicators to be measured and recorded. This is done until extubation and then after 20 min and 30 min after extubation and continued.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304027529N3
Registration date:2013-05-04, 1392/02/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-04, 1392/02/14
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed university
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sounds therapy on agitation and anxiety in patients undergoing coronary artery bypass graft during the weaning of mechanical ventilation
Public title
The effect of sound therapy on agitation and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patients were aged between 18 and 65 years; who were under weaning of mechanical ventilation and undergoing coronary artery bypass graft
Exclusion criteria:drugs and alcohol abuse , hearing problem. Past heart surgery. mental illness are recognized and recorded in the medical record, Severe hemodynamic impairment (inotrope dependence of postoperative, active drainage and what prevents weaning). emergency surgery or re-operation to be performed for any reason. During the intervention, the use of any cause that requires dose-stat of common protocol tranquilizers and sedative medication is needed.changes ASV mode mechanical ventilation to the other modes. high dependence of the positive inotropics, delayed weaning process, unstable vital signs during weaning
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University
Street address
Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran
City
Tehran
Postal code
Approval date
2012-12-15, 1391/09/25
Ethics committee reference number
4/158116
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
agitation level
Timepoint
before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation
Method of measurement
Richmond Agitation Sedation Scale (RASS)
Secondary outcomes
1
Description
anxiety
Timepoint
before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation
Method of measurement
Face anxiety scale (FAS)
2
Description
Systolic blood pressure
Timepoint
before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation
Method of measurement
observation of Monitoring
3
Description
diastolic blood pressure
Timepoint
before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation
Method of measurement
observation of Monitoring
4
Description
Arterial oxygen saturation(sao2)
Timepoint
before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation
Method of measurement
pulse oximeter
5
Description
heart rate
Timepoint
before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation
Method of measurement
observation of Monitoring
6
Description
Mean arterial pressure
Timepoint
before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation
Method of measurement
observation of Monitoring
7
Description
Rrespiratory Rate
Timepoint
before intervention,at intervals of 20 minutes applying technique, after extubation ,after 20 min and 30 min after extubation
Method of measurement
observation of Monitoring
Intervention groups
1
Description
The patients in the experimental group were given nature-based sounds (birds’ song, soothing rain sounds, river stream) through an audiotape via fixed earphones, then 20 min rest. This is done until extubation. The nature sounds were played using a MP3 media player ( Leono Inc., Guangzhou, China) through disposable foam-lined headphones The average sound pressure level was set to 25-50 dB. For all samples is recording anxiety and agitation score
Category
Other
2
Description
The patients assigned to the control group were asked to wear the foam-lined headphone and rest in silence for a similar time frame as the intervention group to minimize unpleasant environmental noises or stimuli.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiatallah University
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Baghiatallah University
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Vice Chancellor for Research of Shahed University
Street address
Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?