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
|
|
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
|
|
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. |