The aim of the study was to investigate the effect of nature-based sound therapy on patients’ anxiety and pain undergoing cardiac catheterization. This was a randomized controlled trial. A purposive sample of 130 patients who were undergoing cardiac catheterization was recruited. Patients were randomly allocated to either the control or the experimental groups (65 patients per each group). In the experimental group, patients received a 20 minutes, between 25 - 50 decibel (dB) sound therapy intervention consisted of birds’ song, soothing rain sounds, and river stream by using a digital MP3 player and a headphone. While the control group received the usual sound environment. Study data were collected by using a demographic questionnaire, the Spielberger’s Anxiety Inventory, Pain scale VAS and a data sheet for documenting hemodynamic parameters. Patients’ data monitored and recorded in before and after intervention, and after cardiac catheterization. The researchers and data monitoring committee will not become aware of what sort of intervention the patients receive.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412047529N5
Registration date:2014-12-21, 1393/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-21, 1393/09/30
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 Vice chancellor for research, Dr. Zahra Kiasalari
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of implementing nature based sounds with placebo on anxiety and pain in patients undergoing cardiac catheterization
Public title
Effect of nature-based sounds on the level of anxiety and pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : patients with first coronary cardiac catheterization; being able to understand and speak Persian; having age of over 18 years; having no hearing impairment; having no drug or alcohol addiction; receiving no anxiolytic medication; needing no emergency cardiac catheterization; not receiving hypertension or anti hypertensive drugs; having 20 number anxiety. Exclusion criteria: not willingness to participate in this study; cancellation of cardiac catheterization due to any reason except patient’s anxiety.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients are randomly allocated to the experiment and control groups (65 patients per each group). Random allocation to intervention and control groups was done by assigning patients to each group every other week.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express
City
Tehran
Postal code
Approval date
2014-04-19, 1393/01/30
Ethics committee reference number
14/9881
Health conditions studied
1
Description of health condition studied
Diseases of the circulatory system
ICD-10 code
I70, I79
ICD-10 code description
Diseases of arteries, arterioles and capillaries
Primary outcomes
1
Description
Blood pressure
Timepoint
Before and after intervention, and after cardiac catheterization
Method of measurement
Sphygmomanometer
2
Description
Anxiety
Timepoint
Before and after intervention, and after cardiac catheterization
Method of measurement
Spielberger questionnaire
3
Description
Respiratory rate
Timepoint
Before and after intervention, and after cardiac catheterization
Method of measurement
Checklist
4
Description
Pulse rate
Timepoint
Before and after intervention, and after cardiac catheterization
Method of measurement
Checklist
5
Description
Oxygen saturation
Timepoint
Before and after intervention, and after cardiac catheterization
Method of measurement
pulse oximeter
6
Description
Pain
Timepoint
Before and after intervention, and after cardiac catheterization
Method of measurement
Pain Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
The patients in the experiment group will receive the nature- based sounds such as birds’ song, soothing rain sounds, and river stream using an audiotape via fixed earphones.
The intervention will be conducted in a quiet room.
that will last for 20 minutes, between 25 - 50 decibel (dB) before the cardiac catheterization.
The level of anxiety (measured by using spielburger questionnaire) and pain (VAS) hemodynamic parameters (recorded in a checklist) are used before and after intervention, while and after cardiac catheterization.
Category
Other
2
Description
In the control group received the usual sound environment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University Vice chancellor for research
Full name of responsible person
Shahed University Vice chancellor for research : Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran Tehran Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice chancellor for research
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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran, Iran,,
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran, Iran
City
Tehran
Postal code
Phone
+98 912 370 6378
Fax
Email
nrejeh@yahoo.co
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way , Tehran ,Iran
City
Tehran
Postal code
Phone
Fax
Email
nrejeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)