| CTRI Number |
CTRI/2025/08/093082 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
TRANSLATION |
| Study Design |
Other |
|
Public Title of Study
|
Translation of a questionnaire on parents playing into Kannada |
|
Scientific Title of Study
|
Translation and content validation of Parent Play Questionnaire in Kannada |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DHARANI R S |
| Designation |
STUDENT |
| Affiliation |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY |
| Address |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY KANKANADY MANGALORE
KRISHNA, NAGABANA, MAJILA, MANGALORE - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8095862005 |
| Fax |
|
| Email |
dharu021999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANUPAMA K |
| Designation |
MPT [PAEDIATRICS] |
| Affiliation |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PEDIATRIC PHYSIOTHERAPY , NO 10, AK BASEMENT 2 FATHER MULLER COLLEGE OF PHYSIOTHERAPY KANKANADY MANGALORE
SRI DEVI KRIPA , VALAENCIA , MANAGALORE 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9901324366 |
| Fax |
|
| Email |
anupamakarkera@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
DHARANI R S |
| Designation |
MPT [PAEDIATRICS] |
| Affiliation |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY |
| Address |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY KANKANADY MANGALORE
KRISHNA, NAGABANA, MAJILA, MANGALORE - 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8095862005 |
| Fax |
|
| Email |
dharu021999@gmail.com |
|
|
Source of Monetary or Material Support
|
| FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE- 575002 |
|
|
Primary Sponsor
|
| Name |
DHARANI R S |
| Address |
FATHER MULLER COLLEGE OF PHYSIOTHERAPY KANKANADY MANGALORE-575002
|
| Type of Sponsor |
Other [SELF] |
|
|
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 DHARANI R S |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL |
FATHER MULLER MEDICAL COLLEGE AND HOSPITAL, OPD, IPD, KANKANADY, MANGALORE - 575002
Dakshina Kannada
KARNATAKA |
8095862005
dharu021999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITEE (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PARENTS OF CHILDREN FROM 3 MONTHS TO 2 YEARS 5 MONTHS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
2.50 Year(s) |
| Gender |
Both |
| Details |
-Parents of children from age 3 months to 2year 5 months.
-Parents who are able to read English and Kannada.
|
|
| ExclusionCriteria |
| Details |
-Infant or toddler with history of genetic abnormality.
-Any Congenital deformity.
-Children on any medication like antiepileptic drugs etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PARENT PLAY QUESTIONNAIRE [PPQ] |
15 MINUTES |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/09/2025 |
| 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 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
|
Translation of the Parent Play Questionnaire [PPQ] in different languages would facilitate better understanding about parent child communication and play. Also, it is essential to approach cultural and linguistic relationship to the community. This parent report measure is designed to determine the frequency of parent and child play, digital media use and play related attitude with their infants. Therefore, by translating PPQ into Kannada and validating it by the experts will promote utilization of this tool for future studies targeting population of Karnataka. |