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CTRI Number  CTRI/2026/03/105669 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 08/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on the quality of life, social adjustment, and self-care habits of children who have had a kidney transplant 
Scientific Title of Study   A cross-sectional study to examine and correlate general self-management behaviours, social adjustments, and quality of life among kidney transplant recipients attending the paediatric transplant clinic 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  Laveesha Talwar 
Designation  M.Sc. Nursing Student 
Affiliation  College of Nursing, AIIMS Delhi 
Address  Porta Cabin 2, Second floor, College of Nursing, AIIMS, New Delhi 110029

South
DELHI
110029
India 
Phone  9911177296  
Fax    
Email  laveeshatalwar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manju A K Rajora 
Designation  Associate Professor 
Affiliation  College of Nursing, AIIMS Delhi 
Address  Room no 2, Ground floor, College of Nursing, AIIMS New Delhi 110029

South
DELHI
110029
India 
Phone  9870260036  
Fax    
Email  manjuakrajora@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Laveesha Talwar 
Designation  M.Sc. Nursing Student 
Affiliation  College of Nursing, AIIMS Delhi 
Address  Porta Cabin 2, Second floor, College of Nursing, AIIMS, New Delhi 110029

South
DELHI
110029
India 
Phone  9911177296  
Fax    
Email  laveeshatalwar@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Laveesha Talwar 
Address  Porta Cabin 2, Second floor, College of Nursing, AIIMS, New Delhi 110029  
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 
Dr Manju A K Rajora  AIIMS, New Delhi  Division of Nephrology, Department of Pediatrics G42, ground floor, Mother and Child Block
South
DELHI 		 9870260036

manjuakrajora@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1 Children and adolescents (aged 5 to 18 years) who have undergone kidney transplantation.
2 Patients who have completed at least 3 months post-transplantation.
3 Patients attending the Pediatric transplant clinic for routine follow-up.
4 Children and parents who are willing to participate and provide assent/consent.
5 Participants who can understand and comprehend Hindi or English.
 
 
ExclusionCriteria 
Details  1 Patients admitted for acute complications (e.g., acute rejection, severe infection) at the time of data collection.
2 Patients with allograft failure requiring return to dialysis.
3 Children with significant developmental delays or cognitive impairment that prevents them from understanding the self-report questionnaire.
4 Patients with other major co-morbidities (e.g., malignancy, severe heart disease) that may independently affect Quality of Life.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To examine the general self-management behaviours among paediatric kidney transplant recipients attending Pediatric transplant clinic at AIIMS New Delhi.  1 time 
 
Secondary Outcome  
Outcome  TimePoints 
1 To examine the social adjustments, and quality of life of paediatric kidney transplant recipients
2 To determine the relationship between general self-management behaviours, social adjustments, and quality of life.
 		 1 time 
 
Target Sample Size   Total Sample Size="83"
Sample Size from India="83" 
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)   01/08/2026 
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="5"
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 - NO
Brief Summary   A descriptive cross-sectional correlational study will be conducted to examine general self-management behaviors, social adjustments, and quality of life among pediatric kidney transplant recipients at a tertiary care hospital in India (AIIMS, New Delhi). The study aims to determine the relationship between adherence to strict post-transplant regimens and the child’s psychosocial well-being. The study population comprises children and adolescents (aged 5-18 years) who have completed at least 3 months post-transplantation. Data collection involves recruiting eligible patients visiting the Pediatric Transplant Clinic using consecutive sampling. Participants will be assessed using the General Self-Management Behaviour Scale (GSMB-PKTR), which includes the BAASIS scale for medication adherence and a lifestyle checklist. Additionally, the PedsQL™ 4.0 Generic Core Scales will be administered to evaluate Quality of Life and social adjustment. 
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