| CTRI Number |
CTRI/2018/05/014251 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
29/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY OF EAR PHONE USE ON AUDITORY REACTION TIME |
|
Scientific Title of Study
|
Study of Ear-Phone use on Auditory Reaction Time
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rathod Ronak |
| Designation |
3rd year resident |
| Affiliation |
Government Medical College,Bhavnagar. |
| Address |
Department of Physiology,fourth floor,Government Medical College,Bhavnagar.
"purusharth",Plot number 4B,Rameshwar Society,Rawapar Road,Morbi-363641.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9978442767 |
| Fax |
|
| Email |
rronak37@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRathod Ronak |
| Designation |
3rd year resident |
| Affiliation |
Government Medical College,Bhavnagar. |
| Address |
Fourth floor,Department of Physiology,Government Medical College,Near ST Bus station,Bhavnagar.
Purusharth,Plot number 4B,Rameshwar Society,Rawapar Road,Morbi-363641
Bhavnagar
GUJARAT
364001
India |
| Phone |
9978442767 |
| Fax |
|
| Email |
rronak37@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChinmay Shah |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College,Bhavnagar. |
| Address |
Department of Physiology,fourth floor,Government Medical College,Bhavnagar.
A-1,Antarix,Opposite Pranav Flats,Ghogha circle,Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9328938008 |
| Fax |
02782430808 |
| Email |
cjshah79@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department Of Physiology for instrument of Reaction Time Machine.No Extra Monetary support Given Except Stipend. |
|
|
Primary Sponsor
|
| Name |
Department of physiology |
| Address |
4th floor,Government medical college,Bhavnagar-364001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rathod Ronak |
Government Medical College. |
4th floor,Department of Physiology,Government Medical College,Bhvanagar-364001
Bhavnagar
GUJARAT |
09978442767
rronak37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Good |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy volunteers between the age group 17-20 years willing to give written informed consent.
Non-alcoholics, Non-smokers.
Earphone users (Since Three Years)
|
|
| ExclusionCriteria |
| Details |
Who are not willing to give written consent.
Pathology or injury to the Upper limb.
History of hearing disorder, sleep disorder , smoking ,alcoholism ,cardiovascular and respiratory diseases or any medication affecting cognitive performance.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| From the above study we can conclude that there is statistically significant difference with and without earphone use. It was found that there is not statistically significant (p0.05) gender difference existed in auditory reaction time. Regarding gender our study concluded that overall male having faster reaction time than female but the difference is statistically insignificant(p0.05). |
This study was done at same time between 3:00 PM to 5:00 PM. on 15th March to 22nd March, 2017. In this study subject selection is random so selection bias is eliminated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
In analysis part it was found that there is no statistical significant (p0.05) difference of overall mean of all three stimuli with and without ear phone use. Separate analysis for males found there is significant (p0.05) increase reaction time for first stimuli but thereafter there is no statistical significant (p0.05) difference for further 2 stimuli. This effect may be due to phenomenon of habituation after first auditory stimuli.
|
This study was done at same time between 3:00 PM to 5:00 PM. on 15th March to 22nd March, 2017. |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2017 |
| Date of Study Completion (India) |
15/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
SUMMARY
From
the above study we can conclude that there is statistically significant difference with and without earphone use. It
was found that there is not statistically significant (p>0.05) gender
difference existed in auditory reaction time.
Regarding gender our study concluded that
overall male having faster reaction time than female but the difference is
statistically insignificant(p>0.05). our study finding suggest that after
intervention like ear phone female react faster than male counterpart compare
to before intervention of ear phone which may suggest that intervention like
ear phone may increase “mental set†in
case of female and increase “distracter set†in case of male after
intervention of ear phone.
The
link between increased risk for collision and ear phone use is also supported
by the epidemiological studies. We believe that raising awareness about the
risks associated with ear phones and driving is an important tool in
discouraging the practice.
Study
recommends that automobile manufacturers invest in promoting the safe use of
ear phone and other hand held devices.
In this study the evidence is clear; driving while using ear phone is
dangerous to the driver, their passengers and others on or near the roadway.
Hands free usage by pedestrian also increase their cognitive distraction so
increase chances of crash among pedestrian also.
The
present study also recommend the importance of limited use of portable music
players among young population and also making them aware of hazards posed by
these devices on hearing, the use of which has become rampant over last few
years. While ear phone driving bans themselves have garnered significant media
and public attention, raising public awareness must be an essential part of any
campaign to reduce this practice. We recommends that in addition to any
legislative action, government and other interested parties sponsor a
comprehensive public awareness campaign to inform the public about the risks of
using ear phone and other hands free devices while driving.
|