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CTRI Number  CTRI/2020/02/023622 [Registered on: 27/02/2020] Trial Registered Prospectively
Last Modified On: 28/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Problem based learning]  
Study Design  Other 
Public Title of Study   Problem Based learning 
Scientific Title of Study   A study to assess the Effectiveness of problem-based learning on knowledge and decision-making abilities regarding management of psychiatric disorder among nursing students in selected nursing colleges of Ambala, Haryana 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepika 
Designation  Post Graduate student 
Affiliation  M.M. College of Nursing, Mullana , Ambala 
Address  M.M. College of Nursing, Mullana , Ambala

Ambala
HARYANA
133207
India 
Phone  9588708035  
Fax    
Email  deepikajay94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Parul Phanden 
Designation  Head of Department Mental Health Nursing Department 
Affiliation  M.M. College of Nursing, Mullana , Ambala 
Address  Room No 15, First Floor, Mental Heath Nursing Department, M.M college of nursing Mullana, Ambala

Ambala
HARYANA
133207
India 
Phone  9992798719  
Fax    
Email  parulphanden@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepika 
Designation  Post Graduate student 
Affiliation  M.M. College of Nursing, Mullana , Ambala 
Address  M.M. College of Nursing, Mullana , Ambala

Ambala
HARYANA
133207
India 
Phone  9588708035  
Fax    
Email  deepikajay94@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
MMIMSR Hospital, Mullana , 133203  
 
Primary Sponsor  
Name  Deepika 
Address  Vill-Majra khurd , Mahender Garh Pin code- 123029 , Haryana 
Type of Sponsor  Other [Self] 
 
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 
Parul Phanden  Maharishi Markandeshwar Hospital  Maharishi Markandeshwar Hospital, Ambala - Yamunanagar Highway
Ambala
HARYANA 
9992798719

parulphanden@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of decision of the Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Problem Based Learning 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable.  Not applicable. 
Intervention  Problem based learning  Teaching program includes different case scenarios and a set of interventions delivered to nursing students in a group of 8-10 with the help of power point slides 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Studying in B.Sc Nursing 3rd and 4th year in selected nursing institutes.
Willing to participate in the study.
 
 
ExclusionCriteria 
Details  Not available at the time of data collection.
Those who are attended less than 3 days of intervention .
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Problem based learning on knowledge and decision making abilities.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Problem based learning on knowledge and decision making abilities.  45 minutes 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   29/02/2020 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Effectiveness of problem based learning on knowledge and decision making abilities  regarding management of  psychiatric disorder  among nursing students  in selected nursing colleges of  Ambala ,Haryana and objectives of  the study :

To assess and evaluate the effectiveness of  problem based learning in terms of Knowledge among nursing students regarding management of  psychiatric disorder  before and after administration of problem based learning.

To assess and evaluate the effectiveness of problem based learning in terms of decision making abilities among nursing students regarding management of  psychiatric disorder  before and after administration of problem based learning .

To find out the relationship of Knowledge and decision making abilities  among nursing students regarding management of  psychiatric disorder before  and after administration of problem based learning. 

To determine the association of Knowledge among nursing students with their selected sample characteristics.  

 To determine the association of decision making abilities among nursing students with their selected sample characteristics.

 
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