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CTRI Number  CTRI/2017/07/008994 [Registered on: 07/07/2017] Trial Registered Retrospectively
Last Modified On: 22/05/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   survey 
Study Design  Cluster Randomized Trial 
Public Title of Study   A study to assess the generational differences between mothers and young adults and the psychological wellbeing of mothers 
Scientific Title of Study   A correlational study to assess the intergenerational ambivalence and psychological wellbeing among mothes of young adults in selected areas of Udupi district, Karnataka. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Steffi Jenifer Quadras 
Designation  M.Sc Nursing student 
Affiliation  Manipal College of Nursing, Manipal, Manipal University 
Address  Dept of mental health nursing, Manipal College of Nursing, Manipal Manipal University
nil
Udupi
KARNATAKA
576104
India 
Phone  7259606728  
Fax    
Email  steffiquadras@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tessy Treesa Jose 
Designation  Professor and HOD 
Affiliation  Manipal College of Nursing, Manipal, Manipal University 
Address  Dept of Mental health nursing Manipal College of Nursing, Manipal Manipal University
nil
Udupi
KARNATAKA
576104
India 
Phone  9844152459  
Fax    
Email  tessy.j@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Steffi Jenifer Quadras 
Designation  M.Sc Nursing student 
Affiliation  Manipal College of Nursing, Manipal, Manipal University 
Address  Dept of mental health nursing Manipal College of Nursing, Manipal Manipal University
nil
Udupi
KARNATAKA
576104
India 
Phone  7259606728  
Fax    
Email  steffiquadras@yahoo.in  
 
Source of Monetary or Material Support  
Manipal College of Nursing, Manipal University Manipal- 576104 
 
Primary Sponsor  
Name  Manipal College of Nursing 
Address  Manipal University- 576104 Udupi district Karnataka 
Type of Sponsor  Research institution and hospital 
 
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 
Steffi Jenifer Quadras  Manipal University  Dept of Mental health nursing Manipal College of Nursing, Manipal Manipal University
Udupi
KARNATAKA 
7259606728
7259606728
steffiquadras@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  mothers who have children with the age group of 18-30 years.
mothers who can read and write. 
 
ExclusionCriteria 
Details  mothers who young adult is married.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
will be able to find the relationship between intergenerational ambivalence and psychological wellbeing of mothers of young adult.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the intergenerational ambivalence between mother and young adult  1 year 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
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)   01/01/2017 
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)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is to partial fullfillment of M.Sc Nursing course. This is a survey and will be able to help in future researchers in the field. 
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