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CTRI Number  CTRI/2025/07/091829 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 27/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [home-based safety educational intervention package]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Preventing Injuries in Young Children: A Study on the Impact of Home Safety Education for Caregivers in Rural Belagavi 
Scientific Title of Study   Evaluate the effect of home-based safety educational intervention package on unintentional childhood injuries of under-five children among primary caregivers in selected rural areas of Belagavi, North Karnataka. A Cluster Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jagadeesh Hubballi 
Designation  Assistant Professor 
Affiliation  KAHER. Belagavi 
Address  KLES Institute of Nursing Sciences. KAHER, Belagavi
KLES Institute of Nursing Sciences. KAHER. Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  08762813171  
Fax    
Email  jagadeeshhubballi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Sangeeta Kharade 
Designation  Professor & Dean 
Affiliation  KAHER Belagavi 
Address  KLES Institute of Nursing Sciences, KAHER, Belagavi
KLES Institute of Nursing Sciences, KAHER, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9481322656  
Fax    
Email  sangeeta.kharde@gmail.com   
 
Details of Contact Person
Public Query  
Name  Jagadeesh Hubballi 
Designation  Assistant Professor 
Affiliation  KAHER INSTITUTE OF NURSING SCIENCES BELAGAVI 
Address  KLES Institute of Nursing Sciences, KAHER, Belagavi
KLES Institute of Nursing Sciences, KAHER, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  08762813171  
Fax    
Email  jagadeeshhubballi@gmail.com  
 
Source of Monetary or Material Support  
KLE ACADEMY OF HIGHER EDUCATION AND RSEARCH BELAGAVI, INDIA, KARNATAKA 590010 
 
Primary Sponsor  
Name  Jagadeesh GHubballi 
Address  KLES Institute of Nursing Sciences, KAHER, Belagavi, Karnataka, 590010 
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 Sangeeta Kharde  Kinaye and Vantamuri PHC of Belagavi Taluk  Kinaye and Vantamuri PHC of Belagavi Taluk, karnataka, pincode:590010
Belgaum
KARNATAKA 		 9481322656

sangeetakharde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of Higher Education and Research Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy primary caretakers of under-five children 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  home-based safety educational intervention package   A total of 45 minutes of a home-based safety educational intervention package includes Introduction (5 minutes), brief about growth and development of children (5 minutes), Common Types of Unintentional Injuries (10 minutes) Risk Factors and Prevention (10 minutes) Creating a safe environment, First Aid and Emergency Response (15 minutes). After the intervention, a 3-month follow-up will be conducted to assess the effect of the program. 
Comparator Agent  Routine care  Pretest will be conducted and routine care, no specific intervention. After 3 months post test will be conducted. At the end of the study, will educate the primary caregivers about the unintentional childhood injuries of under-five children. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children between one to five years of age. Families residing in the study area for more than six months preceding the study.
In case of more than one eligible child in the household, the youngest child will be included.
Caregivers of children who can read, write, and understand the local language
 
 
ExclusionCriteria 
Details  Critically ill children will be excluded from the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
effect of home-based safety educational intervention package among primary caregivers of under-five children in rural areas of Belagavi.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Estimate the prevalence of unintentional childhood injuries of under-five children in rural areas of Belagavi.
Assess the hazards posed by the home environment and their association with unintentional childhood injury patterns among under-five children.
 		 1 year 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   11/08/2025 
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 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  

My study aims to “ evaluate the effect of home-based safety educational intervention package on unintentional childhood injuries of under-five children among primary caregivers in selected rural areas of Belagavi, North Karnataka. A Cluster Randomized Control Trial”. The objectives of the study are to evaluate the effect of home-based safety educational intervention package among primary caregivers of under-five children in rural areas of Belagavi. To estimate the prevalence of unintentional childhood injuries of under-five children in rural areas of Belagavi. To assess the hazards posed by the home environment and their association with unintentional childhood injury patterns among under-five children.Quantitative Evaluative approach. The study will be planned in two phases. Phase I is to identify the prevalence of unintentional childhood injury among under-five children between 1 year to 5 years of 1000 house hold children. Phase II of the study will be  a randomized controlled trial. In Phase I Multistage Cluster randomization technique. PHC will be considered as clusters and houses in the village as cluster units.  In Phase II A random allocation will be carried out at the level of selection of villages by simple random sampling by lottery method to the intervention and control group of 120 house hold children.The outcome of the study: The primary outcome of the study was to assess the prevalence of unintentional childhood injuries in the previous three months. The Environmental Home Hazard Assessment form to observe the home hazards in the house and will be categorized by Low risk, Medium risk, and High risk. Primary Caregiver Knowledge and attitudes (PCA) towards child safety. Unintentional childhood injuries during 3 months follow up.Statistical analysis by descriptive statistics (mean, SD, frequency, and %), Chi-square test for association. Repeated measures of ANOVA followed by Tukeys multiple posthoc procedures. Independent t test or Mann-Whitney U test for inter group comparison. Dependent t test or Wilcoxon matched pairs test intra group comparison. A significance will be set at 5% level of significance (p<0.05)


 
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