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CTRI Number  CTRI/2024/08/072495 [Registered on: 14/08/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Adaptation , validation and translation of Knowledge of Preterm Infant Behavioral questionnaire  
Scientific Title of Study   Cross-cultural adaptation content validation and translation of Knowledge of Preterm Infant Behavior questionnaire  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Minal Ranjeet Dharmapurikar 
Designation  Postgraduate student 
Affiliation  Manipal College of Health Professions 
Address  Department Of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  9405381490  
Fax    
Email  minal.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhamini Krishna Rao 
Designation  Professor 
Affiliation  Manipal College of Health Professions 
Address  Department Of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  9480267152  
Fax    
Email  bhamini.kr@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Selvam Ramachandran 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department Of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal-576104

Udupi
KARNATAKA
576104
India 
Phone  9686738292  
Fax    
Email  selvam.ram@manipal.edu  
 
Source of Monetary or Material Support  
Manipal college of Health Professions , MCHP, Manipal  
 
Primary Sponsor  
Name  Minal Ranjeet Dharmapurikar 
Address  Department Of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal-576104 
Type of Sponsor  Other [Self -funded] 
 
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 Selvam Ramachandran  Dr. TMA Pai Hospital , Udupi  Room no. 27, First floor ,Department of Obg, Court Rd, opp. Old Taluk Office, Brahmagiri, Udupi, Karnataka 576101 Udupi KARNATAKA
Udupi
KARNATAKA 		 966738297

Selvam.ram@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 -2 (student Research )   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  parents of preterm infants  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Parents having preterm infants
Parents who can read and write English
 
 
ExclusionCriteria 
Details  Mothers having psychiatric disorders and are on medications 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Adaptation , validation and translation of the questionnaire  single time point  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "6"
Final Enrollment numbers achieved (India)="6" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2024 
Date of Study Completion (India) 20/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Authors permission will be taken for content validation of questionnaire.Phase 1 : Parents of preterm infants and subject matter experts will get the KPIB questionnaire along
with the options of Understandibility, Clarity , Simplicity , Relevance and space for Comments below
each question . According to which they will validate the content of KPIB questionnaire , Words which
are difficult to understand will be modified by the experts . The questionnaire and a covering letter
stating the goal of validating the questionnaire in the regional context , the rationale behind their
selection, and the significance of their involvement in validating the questionnaire , will be sent to the
validators, who include pediatricians, physiotherapists, occupational therapists, and Parents of
preterm infants who can read and write English.
After validating the questionnaire ,Written inform consent from 6 Parents of preterm infants will be
taken and they will be instructed to rate the questions according to understanding of the questionnaire
and asking them to rate according to likert scale (0-5) . Words which are difficult to understand will be
cross culturally adapted by the committee members.
Phase 2 -
Translation and parallel back translation: To improve its usefulness and acceptability by the local
population, standard method will be followed for translation into the local tongue. Following the
completion of the content validity assessment, two independent individuals who are fluent in both
Kannada and English will translate this questionnaire into the local language, Kannada. A third party
with bilingual knowledge will be included in the discussion of both versions in order to address any
differences or word ambiguities that are found. Following the ultimate agreement, a single version will
be ready. This final copy will be forwarded to an additional blind recipient. This final copy will be
translated back into English (the original language) by someone else who was fully blinded to the
study. Following parallel back translation, a conference of an expert committee will be convened,
comprising language specialists, translators, physiotherapists, and pediatricians, to finalize the form
and ensure that it is equivalent in both Kannada and 
 
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