The purpose of this study was to investigate the effect of nature-based sounds’ intervention on physiological signs of anxiety and agitation in patients under mechanical ventilator support in intensive care units of selected hospitals in Tehran. This study is a randomized controlled trial, 60 patients undergoing 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. Two groups are assessing without earphones, 30 minutes after finishing the procedure.The intensity of anxiety and agitation expressed by the participants were measured using the visual analogue Richmond Agitation Sedation Scale (RASS) and and Faces Anxiety Scale (FAS) for four times. (after intervention,30 minutes after intervention, 60 minutes after intervention, 90 minutes after intervention, 30 minutes after finish of the intervention)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207277529N2
Registration date:2012-08-17, 1391/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-17, 1391/05/27
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
2012-01-05, 1390/10/15
Expected recruitment end date
2012-07-05, 1391/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nature-based sounds’ intervention on physiological signs of anxiety and agit
Public title
effect of nature-based sounds’ intervention on anxiety and agitation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patients were aged between 18 and 65 years; who were under mechanical ventilation support for 48 hours in an ICU ; had Glasgow Coma
Scale Point 9 or above; were able to hear and see ; were not drug-addicted;
were not receiving beta blocker and inotropic support were not taking any neuromuscular blocker agent and antihypertensive drug; had no facial signs of being scared; had no currently using a N-BS intervention; had no psychiatric or neurological illnesses
Exclusion criteria:
Subjects were extubations from mechanical ventilation;
need emergency dose- stat sedative
; Patient withdraws from study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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, Iran
City
Tehran
Postal code
Approval date
2012-05-08, 1391/02/19
Ethics committee reference number
4/148499
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
Timepoint
after intervention,30 minutes after intervention, 60 minutes after intervention, 90 minutes after intervention(end intervention), 30 minutes after finish of the intervention
Method of measurement
The visual analog scale Richmond Agitation Sedation Scale(RASS)
Secondary outcomes
1
Description
agitation
Timepoint
after intervention,30 minutes after intervention, 60 minutes after intervention, 90 minutes after intervention(end intervention), 30 minutes after finish of the intervention
Method of measurement
Faces Anxiety Scale (FAS)
Intervention groups
1
Description
In interventional group who received
the N-BS intervention consisted of 90 minutes of listening to the N-BS (birds’ song, soothing rain sounds, river stream)subjects were assessed in the last thirty minutes without headphones and sounds playing.
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 physiological parameters of agitation and anxiety score
hemodynamic
Category
Other
2
Description
In the control group which received only 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. This group is assessed in the last thirty minutes without headphones and sounds playing.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiatallah University of Medical Sciences
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?