Investigation the effectiveness and non effectiveness of Bainural Beat music to reduce anxiety and pain and increase the satisfaction of patients with eye surgery
Investigating the effecttiveness of Binaural Beat music on reducing anxiety and pain and increasing the satisfaction of patients with eye surgery
Design
In this study, 60 patients who will referred to Imam Khomeini hospital and are eligible to enter the study will be selected conveniently. Participants will be divided into two groups and each participant will be given a code.
Settings and conduct
This study will be done non blinded in Imam Khomeini Hospital in Kermanshah city.Eligible patients, after entering the operating room will be connected to the monitoring by anesthetizing technician and prepared for desiredsurgery with anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no history of eye surgery; the absence of dangerous dysrhythms and heart rate between 60 and 100 beats per minute.
Exclusion criteria: pregnant women; the occurrence of any complications during surgery and anesthesia.
Intervention groups
The intervention group will receive 1 μg of opiate plus Binaural music from the 5 minutes before the surgery until the end of the operation.
The control group will receive one microgram of opiate from the 5 minutes before the start of the operation until the end of the operation
Main outcome variables
Anxiety; rate of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N89
Registration date:2018-04-02, 1397/01/13
Registration timing:retrospective
Last update:2018-04-02, 1397/01/13
Update count:0
Registration date
2018-04-02, 1397/01/13
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness and non effectiveness of Bainural Beat music to reduce anxiety and pain and increase the satisfaction of patients with eye surgery
Public title
Investigation the effectiveness of Bainural Beat music to reduce anxiety and pain and increase the satisfaction of patients with eye surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of eye surgery
Hemodynamic stability (systolic blood pressure greater than 90 mmHg and less than 140 mmHg)
The absence of dangerous dysrhythms and heart rate between 60 and 100 beats per minute
Exclusion criteria:
History of neurological diseases or spatial scarring
Seizure
A history of mental illness
Pregnant women
Drug use
The occurrence of any complications during surgery and anesthesia
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-01-17, 1396/10/27
Ethics committee reference number
IR.KUMS.REC.1396.573
Health conditions studied
1
Description of health condition studied
preoperative anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after surgery
Method of measurement
Based on State-Trait Anxiety Inventory (STAI)
2
Description
Rate of pain
Timepoint
Before and after surgery
Method of measurement
VAS Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 1 μg of opiate plus Binaural music from the 5 minutes before the surgery until the end of the operation.
Category
Treatment - Other
2
Description
The control group will receive one microgram of opiate from the 5 minutes before the start of the operation until the end of the operation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Amin Jalilian
Street address
Street Naghliyeh
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 9104
Email
amin.jalilian.md@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice chancellor for research of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0011
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amin Jalilian
Position
Anesthesiology residents
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
amin.jalilian.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Bahman Roshani
Position
Faculty Member of Medical University
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 833427634
Email
Broshani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amin Jalilian
Position
Anesthesiology residents
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
amin.jalilian.md@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
En In a 20-day period, the documents will be sent e-mail