| CTRI Number |
CTRI/2024/05/067690 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Study- Phenomenological hermeneutical study |
| Study Design |
Other |
|
Public Title of Study
|
Lived experiences and perspectives of parents in parenting a child with kidney transplantation |
|
Scientific Title of Study
|
A qualitative study to explore lived experiences and perspectives of parents in parenting a child with kidney transplantation at AIIMS, New Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Nim |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS, New Delhi |
| Address |
Porta Canin-1, 2nd floor, College of Nursing, All India Institute of Medical Sciences, New Delhi-110029.
South
DELHI
110029
India |
| Phone |
9971048290 |
| Fax |
|
| Email |
swatinim1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju AK Rajora |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No.-2, Ground floor, College of Nursing, All India Institute of Medical Sciences, New Delhi-110029.
South
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
manjuakrajora@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju AK Rajora |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No.-2, Ground Floor, College of Nursing, All India Institute of Medical Sciences, New Delhi-110029.
South
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
manjuakrajora@aiims.edu |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029. |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
All India Institute of Medical Sciences, New Delhi-110029 |
| 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 |
| Dr Manju AK Rajora |
All India Institute of Medical Sciences , New Delhi |
Transplant Clinic, Ground floor, Pediatric OPD, Mother and child Block, AIIMS, New Delhi.
South
DELHI |
9870260036
manjuakrajora@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of children who had undergone kidney transplantation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for parent
Those who are willing to participate. Parents able to understand Hindi or English. Parents who are healthy, co-operative, alert and well oriented in time.
Inclusion criteria for children
Children age is between 5 to 18 years. Children who had undergone kidney transplantation before 6 months but within last 10 years.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for parent
Parent not living with the child. Parent having mental disease.
Exclusion criteria for children
Child with poorly functional kidney transplant or eGFR less than 30ml per min per 1.73m2. Child admitted in last 2 weeks or currently in ward for any complications. Child not accompanied by parent in OPD.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lived experiences of parents |
During Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perspectives of parents |
During Study |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/08/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
It is a phenomenological hermeneutical study. This study aim to explore lived experiences and persepectives of parent in parenting a child with kidney transplantation at AIIMS, New Delhi. This study is delimited to AIIMS, New Delhi. Setting of study is Pediatric OPD, AIIMS New Delhi and population is parents of children who had undergone kidney transplantation. Participants will be selected purposively and Sample size will depend on the data saturation. The data collection will be done through Socio-demographic data tool and semi-structured interview tool. The interview will be conducted and will approximately lasts for 45 min. |