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CTRI Number  CTRI/2024/05/066712 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between Internet Addiction and Sleep Quality Among Medical Students 
Scientific Title of Study   Association of internet addiction with sleep quality among UG Medical students : Cross sectional study  
Trial Acronym  IAASQ 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dhruti A Joshi 
Designation  Resident of Physiology 
Affiliation  Government Medical College Bhavnagar. 
Address  Resident room, Department of Physiology , Government Medical College, Jail road, Bhavnagar.
Nil
Bhavnagar
GUJARAT
364002
India 
Phone  9054142868  
Fax    
Email  dhrutijoshi1810@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjula Jamliya 
Designation  Associate professor of Physiology  
Affiliation  Government Medical College Bhavnagar 
Address  Room no.3, Department of Physiology , Government Medical College, Jail road, Bhavnagar.
NIL
Bhavnagar
GUJARAT
364002
India 
Phone  9427511179  
Fax    
Email  drmanjulajamliya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dhruti A Joshi 
Designation  Resident  
Affiliation  Government Medical College Bhavnagar 
Address  Resident room, Department of Physiology , Government Medical College, Jail road, Bhavnagar.
NIL

GUJARAT
364002
India 
Phone  9054142868  
Fax    
Email  dhrutijoshi1810@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Dhruti A Joshi 
Address  Resident room Department of Physiology Government medical college jail road Bhavnagar 364002 Gujarat India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhruti A Joshi  Government Medical College Bhavnagar  Resident room Department of Physiology Bhavnagar
Bhavnagar
GUJARAT 		 9054142868

dhrutijoshi1810@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Govt Medical College, Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Physically, mentally, socially healthy and do not have any significant medical condition or illness.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Apparently healthy Individuals who is using Internet.
 
 
ExclusionCriteria 
Details  Smoker, Alcoholic and Use of Anti psychotic or Sedative medication
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
score in Pittsburgh sleep quality Index
: Sore in Internet Addiction Test
 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dhrutijoshi1810@gmail.com].

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 01-05-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
•Approval  will be taken from the Ethics committee, GMC Bhavnagar
• Participants will be  recruited from medical undergraduate students by Random Sampling Method.
•Informed consent  will be obtained from all the participants in the study.
•Socio-demographic details (like Age , Gender , Socioeconomic status , Residential area)will be collected.
•Data of Internet Addiction Score and Sleep quality Score of participants will be obtained in hard copy after explaining it in vernacular language.
•Data will be entered in master chart.
•Appropriate statistical tests will be applied
 
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