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CTRI Number  CTRI/2018/01/011070 [Registered on: 01/01/2018] Trial Registered Prospectively
Last Modified On: 27/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   “understand the quality of colostomy care video teaching on Knowledge and practice regarding colostomy care among parents or who are giving care to colostomy child in department of pediatric surgery Sanjay Gandhi Post Graduation Institute Of Medical Sciences Lucknow UP” 
Scientific Title of Study   “An Evaluative study to assess the Effectiveness of a Video Assisted Teaching Module on Knowledge and Practice regarding Home based Colostomy care of children among Primary care givers in selected hospital Lucknow Uttar Pradesh”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kurvatteppa Halemani 
Designation  Sister Grade II 
Affiliation  Pediatric surgery,2nd floor PMSSY block,Sanjay Gandhi Post Graduation Institute Of medical Sciences  
Address  Mr.Kurvatteppa Halemani. College of Nursing Sanjay Gandhi Post Graduation Institute Of Medical Sciences Lucknow
Mr.Kurvatteppa Halemani. College Of Nursing Sanjay Gandhi Post Graduation Institute Of medical Sciences Lucknow
Lucknow
UTTAR PRADESH
226014
India 
Phone  8574262723  
Fax    
Email  kurru.hali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashidhara Y N  
Designation  Professor and head  
Affiliation  Department of Community Health Nursing Manipal College of Nursing Manipal University 
Address  Department of Community Health Nursing Manipal College of Nursing Manipal University Mananipal Udupi district Karnatka
Department of Community Health Nursing Manipal College of Nursing Manipal University Mananipal Udupi district Karnatka
Udupi
KARNATAKA
576104
India 
Phone  9886344627  
Fax    
Email  shashidhara.yn@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Kurvatteppa Halemani 
Designation  Sister Grade II 
Affiliation  Pediatric surgery 2nd floor PMSSY block Sanjay Gandhi Post Graduation Institute Of Medical Sciences  
Address  Mr.Kurvatteppa Halemani College Of Nursing Sanjay Gandhi Post Graduation Institute Of medical Sciences Lucknow
Mr.Kurvatteppa Halemani College Of Nursing Sanjay Gandhi Post Graduation Institute Of Medical Sciences Lucknow
Lucknow
UTTAR PRADESH
226014
India 
Phone  8574262723  
Fax    
Email  kurru.hali@gmail.com  
 
Source of Monetary or Material Support  
The study will be conducted in the Sanjay Gandhi Post graduation institute department of pediatric surgery Lucknow UP. 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
KURVATTEPPA HALEMANI  SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCE  Pediatric surgery ward,second floor PMSSY Block.
Lucknow
UTTAR PRADESH 		 8574262723

kurru.hali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBHA HOSPITAL MANIPAL KARNATAKA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The study will be educated the primary caregivers of colostomy children 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  not applicable  not applicable 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Who have children with colostomy between 0-12 years.
2.Who can understand Hindi or English.
3.Caregivers,who are willing to participate in the study.

 
 
ExclusionCriteria 
Details  1.Who are admitted for colostomy closure.
2.Caregiver,who are not able to read and write Hindi or English.
3.Children,who are physiological unstable.
4.Caregiver,who are not able to cooperate throughout the period of study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess knowledge and practice skills among primary care givers of colostomy children   Assess the knowledge and practice skills before my colostomy video intervention among primary care givers of colostomy children who have admitted in paediatric surgery ward.SGPGIMS Lucknow 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the knowledge and practice skills among home based colostomy caregivers and determine the effectiveness of video teaching programme  Assess the knowledge and practice skills After my colostomy video intervention among primary care givers of colostomy children who have admitted in paediatric surgery ward.SGPGIMS Lucknow 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 1 
Date of First Enrollment (India)   03/01/2018 
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   1.Aazam Dabirian Farideh, Y. i. (2010). Qualitative of life in ostomy patient :a qualitative study,Nursing 2midwifery school. 1-5. 2.H.M, F. (2016). Pre-postopertive stoma education and gudence within an enhance recovery after surgery (ERAS) Programme reduce length of hospital stay in colorectal surgery. International journal of surgery . 3.Hatice K, K. D. (2014). Effect of planned group interactions on the social adaptation of individual with an stoma,A quantative study. Journal of clinical nursing , 1-14.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   TITLE 
“An Evaluative study to Assess the Effectiveness of a Video Assisted Teaching Module On Knowledge And Practice Regarding Home Based Colostomy Care Of Children Among Primary Care Givers In Selected Hospital Lucknow UP”.
PURPOSE 
The purpose of this study to determine the knowledge and practice among primary care givers (HBCC), and develop a validated video-based learning material to enhance the ability to provide appropriate care to the children with colostomy at home setting. Further, the same video can be used at the time of discharge as Health education to all the primary care givers of children with colostomy. 
OBJECTIVES
1.Assess the knowledge of primary caregivers on home based colostomy care of children.2 Assess the self-reported practice on home based colostomy care of children among primary care givers 3. Determine the effectiveness of video assisted teaching module on knowledge and practice regarding home based colostomy care of children among primary care givers.
 HYPOTHESIS 
There will be significant mean difference between pre and post test knowledge scores regarding home based colostomy care of children among primary care givers.2 There will be significant mean difference between pre and post-test practice scores regarding home based colostomy care of children among primary care givers.
Vb            VARIABLE 
          1.Dependent Variable: knowledge and practice on home based colostomy care.2 Independent variable: Video assisted teaching module.3 Demographic variables: Age,Gender,Religion,Caregiver’s relationship to child,Education status,Occupation,Family income,Type of family.Number of child
 
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