| CTRI Number |
CTRI/2025/11/097098 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Delphi study |
| Study Design |
Other |
|
Public Title of Study
|
A study to develop and validate a questionnaire on understanding parents knowledge and views of early physiotherapy for babies in neonatal intensive care unit. |
|
Scientific Title of Study
|
Development and validation of questionnaire on parental knowledge and perception about early physiotherapy intervention of babies in neonatal intensive care unit : An E-Delphi 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 Mehreen Bandmaster |
| Designation |
Assistant Professor Department Of Pediatric Physiotherapy |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced physiotherapy center department of pediatric physiotherapy, OPD No. 39, sagar floor , Belagavi,Karnataka-590010, India
Belgaum
KARNATAKA
590010
India |
| Phone |
8200734751 |
| Fax |
|
| Email |
mehreenbm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehreen Bandmaster |
| Designation |
Assistant Professor Department Of Pediatric Physiotherapy |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced physiotherapy center department of pediatric physiotherapy, OPD No. 39, sagar floor , Belagavi,Karnataka-590010, India
Belgaum
KARNATAKA
590010
India |
| Phone |
8200734751 |
| Fax |
|
| Email |
mehreenbm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Tirvir |
| Designation |
Intern |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced physiotherapy center department of pediatric physiotherapy, OPD No. 39, sagar floor , Belagavi,Karnataka-590010, India
Belgaum
KARNATAKA
590010
India |
| Phone |
7688839936 |
| Fax |
|
| Email |
shivanitirvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore hospital and research center, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy ,JNMC Campus, Nehru Nagar, Belagavi-590010 |
| 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 Mehreen Bandmaster |
KAHER Institute of physiotherapy |
Advanced physiotherapy center ,OPD number 39 , Sagar floor ,department of pediatric physiotherapy , Belagavi Karnataka - 590010 India
Belgaum
KARNATAKA |
8200734751
mehreenbm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KLE ACADEMY OF HIGHER EDUCATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Parents of neonates admitted to the NICU for at least 48-72 hours
Parents who can understand and communicate in the local language or English
Parents who willingly give informed consent for participation
Parents who are 18 or more than 18 years of age |
|
| ExclusionCriteria |
| Details |
Parents who are healthcare professionals
Parents of neonates where physiotherapy is not provided or applicable
Parents of neonates expected to be discharged / transferred within 48 hours of admission
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop and validate a questionnaire to assess the level of parental knowledge and perception about early physiotherapy intervention for babies in NICU |
Baseline and throughout the study for two weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish expert consensus through the delphi method for questionnaire development to conduct a pilot study to assess clarity & validation of the questionnaire & to analyze parental knowledge & perception levels. |
Delphi rounds & pilot testing during development phase, validity & reliability testing during validation phase.
Including baseline & two-weeks. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
12/11/2025 |
| 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="0"
Months="6"
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 research project aims to develop and validate a questionnaire assessing parental knowledge and perceptions regarding early physiotherapy interventions for neonates in the Neonatal Intensive Care Unit (NICU). Recognizing the emotional stress and limited awareness among parents, the study emphasizes the importance of family-centered care and early physiotherapy techniques such as positioning, handling, massage, and kangaroo care in promoting neurodevelopment and bonding. Using the Delphi method, the study involves expert input to ensure content validity and relevance, ultimately creating a reliable tool to guide parental education and engagement in NICU-based physiotherapy. The project is structured across development, validation, and pilot testing phases, with a sample size of 36 parents from a tertiary care hospital in Belagavi. |