| CTRI Number |
CTRI/2026/01/100187 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Well-being and stress in parents of children with cancer |
|
Scientific Title of Study
|
Well-being and stress in parents of children with cancer : Cross sectional
study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor and Head of the Department |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of Pediatric Oncology,Kasturba Medical College, Manipal, India
Udupi
KARNATAKA
576102
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor and Head of the Department |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of Pediatric Oncology,Kasturba Medical College, Manipal, India
Udupi
KARNATAKA
576102
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor and Head of the Department |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of Pediatric Oncology,Kasturba Medical College, Manipal, India
Udupi
KARNATAKA
576102
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Manipal |
|
|
Primary Sponsor
|
| Name |
N.A |
| Address |
N.A |
| Type of Sponsor |
Other [N.A] |
|
|
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 Vasudeva Bhat K |
Kasturba Medical College, Manipal |
Department of Pediatric Oncology, Women and Child Block, Kasturba Medical College, Manipal,576104
Udupi
KARNATAKA |
9619114703
vasudev.bhat@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with no chronic illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Parents or primary caregivers of children aged 0–18 years diagnosed with solid or haematological type of cancer.
2. Parents of children who are currently receiving treatment or are on follow-up care at the hospital.
3. Parents who are willing to give informed consent.
4. Parents who are able to understand and complete the study questionnaires in English or Kannada |
|
| ExclusionCriteria |
| Details |
1.Parents who are diagnosed with any known psychiatric illness that could interfere with their ability to
participate (as per clinical records or history).
2.Parents who have experienced the recent death (within the past 3 months) of their child (to avoid
additional emotional burden).
3. Parents who are unwilling or unable to provide informed consent.
4. Parents who have already participated in a similar psychological assessment study within the last 6
months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Parental Stress |
cross-sectional |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Well-Being |
Cross-sectional |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
02/02/2026 |
| 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="1"
Months="0"
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
|
This prospective cross-sectional study assesses stress and well-being levels among 200 parents of children aged 0-18 years with cancer receiving treatment or follow-up care at a pediatric oncology department. Parental stress will be measured using the Parental Stress Scale (PSS), and well-being via the WHO-5 Wellbeing Index, with correlation analysis to explore their relationship (Pearson’s or Spearman’s based on data distribution). The hypothesis posits a significant inverse association between parental stress and well-being scores. |