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CTRI Number  CTRI/2018/07/014982 [Registered on: 20/07/2018] Trial Registered Prospectively
Last Modified On: 17/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To assess the effectiveness of participation of family members in after surgery care of the children with having birth defect in the heart and they are admitted in Advance Cardiac Center at PGIMER, Chandigarh 2017-19. 
Scientific Title of Study   A Quasi Experimental study to assess the effectiveness of the involvement of family caregivers in post- operative care on selected outcome variables among children suffering with Congenital Heart Diseases admitted/attending selected CTVS units, ACC, PGIMER, Chandigarh 2017-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harpreet Kaur 
Designation  Msc Nursing Student 
Affiliation  NINE PGIMER Chandigarh 
Address  National Institute of Nursing Education Post Graduate Institute of Medical Education and Research Sector-12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9888801074  
Fax    
Email  preet2leeza@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Neenavir Singh 
Designation  Lecturer 
Affiliation  NINE PGIMER Chandigarh 
Address  National Institute of Nursing Education Post Graduate Institute of Medical Education and Research Sector-12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8146552482  
Fax    
Email  neenasingh_2@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Harpreet Kaur 
Designation  Msc Nursing Student 
Affiliation  NINE PGIMER Chandigarh 
Address  National Institute of Nursing Education Post Graduate Institute of Medical Education and Research Sector-12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9888801074  
Fax    
Email  preet2leeza@yahoo.co.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Harpreet Kaur 
Address  Msc Nursing Student NINE PGIMER Chandigarh 
Type of Sponsor  Other [self sponsored] 
 
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 
Harpreet Kaur  PGIMER, Chandigarh  CTVS Wards and OPD, Advance Cardiac Center PGIMER, Chandigarh
Chandigarh
CHANDIGARH 		 9888801074

preet2leeza@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregiver of children suffering with Congenital Heart Disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Family caregivers of children suffering with congenital heart disease  Experimental group protocol for involvement of family caregivers in the post-operative care of children suffering with Congenital Heart Diseases admitted in ACC, PGIMER, Chandigarh. Control group- Routine care 
Intervention  Non Randomized active control trial  Experimental group-evaluate the effectiveness of the involvement of family caregivers in post-operative care and Protocol for involvement of family in the post operative care .Control group-Routine care  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children (1-12 years) undergoing cardiac surgery for Congenital Heart Disease.
Caregivers of Children (1-12 years) undergoing cardiac surgery for Congenital Heart Disease who will be willing to participate.
 
 
ExclusionCriteria 
Details  Family caregivers not willing to participate in the study.

Blind participants.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Children
Postoperative pain Early ambulation Prevention of Surgical site infection
Maintenance of Hygiene
Length of hospital stay
Readmission in the hospital
 		 Personal and Clinical Profile of child
Information profile of the caregivers
Knowledge questionnaire for caregivers about Congenital Heart Disease
POSTOPERATIVE RECOVERY PERAMETER SHEET
Wong-Baker Faces Pain Rating Scale
FOLLOW UP COMPLIANCE CHECK LIST 
 
Secondary Outcome  
Outcome  TimePoints 
Family Caregivers:
 Satisfaction on post-operative care of children.
 Skill development in post-operative care of children.
 		 Hand washing,Oral care,axillary temperature and sponge bath procedure competency checklist for caregivers
SATISFACTION FORM FOR CAREGIVERS REGARDING POST OPERATIVE INTERVENTIONS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/07/2018 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Research Statement

A Quasi Experimental study to assess the effectiveness of the involvement of family caregivers in post- operative care on selected outcome variables among children suffering with Congenital Heart Diseases admitted/attending selected CTVS units, ACC, PGIMER, Chandigarh 2017-19

Research approach used in study is Quantitative.

Objectives of my study are:

·       To develop and implement protocol for involvement of family caregivers in the post-operative care of children suffering with Congenital Heart Diseases admitted in ACC, PGIMER, Chandigarh.

·       To evaluate the effectiveness of the involvement of family caregivers in post-operative care of children suffering with Congenital Heart Disease in terms of selected variables.

·       Independent variable- Protocol for involvement of family in the post operative care .

·       Dependent variables

Children:

Ø   Postoperative pain

Ø   Early ambulation

Ø  Prevention of Surgical site infection

Ø  Maintenance of Hygiene

Ø  Length of hospital stay

Ø  Readmission in the hospital

Family Caregivers:

u  Satisfaction on post-operative care of children.

u   Skill development in post-operative care of children.

Research setting is Cardio Thoracic and Vascular surgery units of Advance Cardiac Centre, PGIMER, Chandigarh

My study Target population is Family caregivers of children undergoing cardiac surgeries for Congenital Heart and Accessible population is Family caregivers of children undergoing cardiac surgeries for Congenital Heart Diseases in ACC, PGIMER, Chandigarh during July -September 2018.

Total enumeration sampling techniques is using in this study

Sample size is 60 in total and 30 in control group and 30 in Experimental group

In this study Control group, I will have enrolled 30 children and their 30 caregivers and same in Experimental group i.e. 30 children and their caregivers.

I have taken from Ethical Clearance from Institute Ethics Committee of PGIMER, Chandigarh Permission from Head, Department of Cardio Thoracic and Vascular Surgery PGIMER, Chandigarh and written Informed consent from participants.

My Protocol is involvement of family caregivers in post-operative care of children suffering from Congenital Heart. This Protocol will be beneficial for the caregivers of children undergoing post-operative cardiac surgeries and CHD children.

I will Pre-assess the knowledge of control and experimental group before proceeding the study.

I am using these tools for data collection:

·       Personal and Clinical Profile of child

·       Information profile of the caregivers

·       Knowledge questionnaire for caregivers about Congenital Heart Disease

·       Post-operative recovery parameter sheet

·       Wong-Baker Faces Pain Rating Scale

·       Follow-up compliance check list

·       Hand washing, Oral care, axillary temperature and sponge bath procedure competency checklist for caregivers

·       Satisfaction form for caregivers regarding post-operative interventions

After that I will analysis my data with the help of descriptive and inferential statistical, present my data into table and figures and dissemination of findings.

 

 

 

 
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