1. Home
  2. Approved trials
  3. » فارسی

The effect of familiar voice auditory stimulation on anesthesia recovery among patients under gone to rhinoplasty

Protocol summary

Study aim
Determination of the effect of familiar voice auditory stimulation on anesthesia recovery among patients under gone to rhinoplasty
Design
A randomized, single-blind, placebo-controlled clinical trial with a sample size of eighty
Settings and conduct
One-blind clinical trial in patients undergoing rhinoplasty in the recovery ward with the same anesthesia protocol, complete randomization to the intervention and control groups. In the intervention group despite receiving routine nursing care in recovery, they receive a stimulation of the auditory sensation that captures the recorded voice of the individual accompanying the patient for an average of three minutes continuously for fifteen minutes in the recovery unit using the MP3 player via headphones. The second group as the control group, despite having headphones in the ear, does not receive any audio from the headphones and receive only routine nursing care.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients undergoing rhinoplasty, obtaining informed consent from the patient and their family, age range 18 to 60 years, no history of hearing impairment, patients being classified as Class 1 Physical Examination by the American Society of Experts; Exclusion criteria included body mass index more than thirty-five and less than eighteen and a half, mental illness, drug and psychiatric disorders, heart, lung, kidney and liver disease.
Intervention groups
In the intervention group, in spite of receiving routine nursing care, they receive auditory stimulation, which is the recorded voice of the individual accompanying the patient with the specified content, in the postoperative recovery unit through the headphones and the control group only receive routine nursing care and no audio from their headphones.
Main outcome variables
Duration of anesthesia recovery; hemodynamic status; complications of anesthesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190707044129N1
Registration date: 2019-12-29, 1398/10/08
Registration timing: registered_while_recruiting

Last update: 2019-12-29, 1398/10/08
Update count: 0
Registration date
2019-12-29, 1398/10/08
Registrant information
Name
Shamsaldin Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3336 1577
Email address
shamsodin.mohammadi1396@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-29, 1398/10/08
Expected recruitment end date
2020-03-30, 1399/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of familiar voice auditory stimulation on anesthesia recovery among patients under gone to rhinoplasty
Public title
The effect of auditory stimulation on anesthesia recovery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are candidates for rhinoplasty Patients are classified in class 1 in the classification of the physical condition of the American Society of Anesthesiologists Patients are between the ages of 18 and 60 years Getting informed consent from the patient and his or her family Patients with no history of hearing impairment
Exclusion criteria:
Body mass index is more than thirty five and less than eighteen and a half The presence of mental illness Drug Addiction and Psychoanalysis Heart disease, lung, kidney, liver disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the study, simple randomization with individual unit is used, so that patients are randomly assigned to two intervention and control groups using random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Before the surgery and after consultation with the patient regarding the choice of the accompanying the patient and the informed consent of the patient and his or her family, the recorded voice accompanying the patient to stimulate the postoperative auditory hearing is used in recovery in the intervention group, But the patient is unaware of being in the intervention or control group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd., Alem Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.SSU.SPH.REC.1398.047

Health conditions studied

1

Description of health condition studied
Anesthesia recovery
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
Average of anesthesia recovery time
Timepoint
Since the removal of the endotracheal tract to a score of 9 out of 10
Method of measurement
A valid and standard Aldert Score checklist

Secondary outcomes

1

Description
Hemodynamic status
Timepoint
Before anesthesia, before the auditory stimulation, 5, 10 and 15 minutes after the auditory stimulation, the discharge time of recovery
Method of measurement
Monitoring device

2

Description
Complications of anesthesia
Timepoint
Since the removal of the endotracheal tract until recovery ward discharge
Method of measurement
Check list

Intervention groups

1

Description
Intervention group: In addition to receiving routine nursing care in recovery, the auditory stimulation is performed in a continuous recovery unit with a patient's accompanying and patient's consultation, and an average of 3 minutes, for 15 minutes. The use of MP3 player and headphones with sound intensity in the normal range of hearing is 50 to 60 db
Category
Prevention

2

Description
Control group: This group only receives routine nursing care in recovery, but despite having headphones, no sound will be delivered to them.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Injuries and burns hospital
Full name of responsible person
Mohamadhosein Dehghani
Street address
Injuries and burns hospital, Shaheed Paknezhad Boulevard, Moallem Square
City
Yazd
Province
Yazd
Postal code
8917615469
Phone
+98 35 3525 0093
Fax
+98 35 3525 6555
Email
yazd-burn-ssu@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences Yazd., Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Fax
+98 35 3725 4750
Email
mirzaeim@med.usyd.edu.au
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Yazd University of Medical Sciences
Full name of responsible person
Shamsodin Mohammadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Operating Room
Street address
Ayatollah Kashani Hospital
City
Esfahan
Province
Isfehan
Postal code
8139687986
Phone
+98 31 3336 1577
Email
shamsodin.mohammadi1396@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shamsodin Mohammadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Operating room
Street address
Ayatollah Kashani Hospital
City
Esfahan
Province
Isfehan
Postal code
8139687986
Phone
+98 31 3336 1577
Email
shamsodin.mohammadi1396@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shamsodin Mohammadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Operating Room
Street address
Ayatollah Kashani Hospital
City
Esfahan
Province
Isfehan
Postal code
8139687986
Phone
+98 31 3336 1577
Email
shamsodin.mohammadi1396@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 3 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Esfahan Ayatollah Kashani Hospital
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.
Comments
Loading...