Evaluation of the effect of using sound proof headphones during orthopedic surgery with spinal anesthesia on patients' physiological indices and length of staying in recovery room: a controlled clinical trial in selected hospitals of Isfahan in 2021
Determine the effect of using soundproof headphone on patients' physiologic indices and length of staying in recovery room in orthopedic surgeries with spinal anesthesia.
Design
Clinical trial, one side blinded, parallel group on 184 patients. In order to divide patients to intervention and control groups odd and even numbers will be allocated to patients with out paying attention to their age, sex, kind of surgery and length of it for randomization
Settings and conduct
This study is on the effect of noise on the patients' physiological parameters in orthopedic procedures and length of their stay in the recovery room. Using soundproof headphone, we try to reduce the noise heard by patients and measure its effect on patients' physiological parameters and how long they stay in the recovery room. In the intervention group, soundproof headphones are placed on the patients' ears during the operation, but the control group goes through the usual procedure. this study will be done in Kashan hospital of Isfahan. The data analyzer does not know which patient or group the information belongs to.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1. Age between 18-65
2. Operations less than 2 hours
3. Surgeries except amputation
4. Patients with normal mental condition
5. Having normal hearing
Exclusion criteria:
Surgeries except orthopedic surgery
General anesthesia
Patients with emergency
Intervention groups
In order to not hearing noise, soundproof headphone will be used for patients in intervention group and patients in control group will not get headphone and then their length of staying in recovery room and physiologic indices will be compared with each other.
Main outcome variables
Systolic blood pressure؛ diastolic blood pressure؛ heat rate؛ respiratory rate؛ oxygen saturation؛ length of staying in recovery room
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051551N1
Registration date:2021-11-10, 1400/08/19
Registration timing:prospective
Last update:2021-11-10, 1400/08/19
Update count:0
Registration date
2021-11-10, 1400/08/19
Registrant information
Name
saeed belyad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3383 0376
Email address
saeedbelyad76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using sound proof headphones during orthopedic surgery with spinal anesthesia on patients' physiological indices and length of staying in recovery room: a controlled clinical trial in selected hospitals of Isfahan in 2021
Public title
The effect of using soundproof headphone on patients' physiological indices and duration of recovery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are aged between 18-65 years
Surgeries that last less than 2 hours
Surgeries except amputation
Patients without mental illness
Having normal hearing
Exclusion criteria:
Surgeries except orthopedic surgeries
Patients with general anesthesia
Patients with emergency conditions
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
184
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Person who analyzes data doesn't know that which data belong to which group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
4183634819
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.076
Health conditions studied
1
Description of health condition studied
Orthopedic surgeries with spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of staying in recovery room
Timepoint
When patients enter to the recovery room and when patients leave it
Method of measurement
Record time in checklist
2
Description
Systolic blood pressure
Timepoint
Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room
Method of measurement
Record in checklist
3
Description
Diastolic blood pressure
Timepoint
Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room
Method of measurement
Record in checklist
4
Description
Heart rate
Timepoint
Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room
Method of measurement
Record in checklist
5
Description
Respiratory rate
Timepoint
Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room
Method of measurement
Record in checklist
6
Description
Oxygen saturation
Timepoint
Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room
Method of measurement
Record in checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: using Hellberg secure 2 soundproof headphone to reduce hearing noises in patients with spinal anesthesia. the headphone will be placed on patient's ears after inducing of spinal anesthesia and it will be removed at the end of surgery when suturing is done. then we will monitor patient's physiologic indices in 5 points and also we will measure length of staying in recovery room.
Category
Diagnosis
2
Description
Control group: soundproof headphone won't be used for patients in control group and usual surgery will be done for patients.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Farhad Jalali
Street address
Kashani Ave, Navab Blvd, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
4183634819
Phone
+98 13 3336 0483
Email
Saeedbelyad76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Akram Arabi
Street address
Hezarjerib Ave, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
4183634819
Phone
+98 13 3336 0483
Email
Aarabi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Belyad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
surgical technology
Street address
Keshavarzi Blvd., Keshavarzi Sq. Kosar dormitory
City
Isfahan
Province
Isfehan
Postal code
4183634819
Phone
+98 13 3336 0483
Email
saeedbelyad76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Akram Arabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
4183634819
Phone
+98 13 3336 0483
Email
Aarabi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeed Belyad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Operating room
Street address
No. 12, Keshavarzi Ave., Keshavarzi Blvd., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
4183634819
Phone
+98 13 3383 0376
Fax
Email
Saeedbelyad76@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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data including data related to main variables like "length of staying in recovery room" and " mean of physiologic indices" and also background variables like kind of surgery, age and sex of patients will be published after unrecognizing patients.
When the data will become available and for how long
Six months after gathering results
To whom data/document is available
Researchers working in universities will get access to data.
Under which criteria data/document could be used
Using data for :
1.Therapeutic goals
2. research goals
From where data/document is obtainable
Saeed Belyad
0098 937 2580188
What processes are involved for a request to access data/document
Sending a request by calling and providing evidence for use in research or treatment and receiving data in less than a week