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CTRI Number  CTRI/2024/07/070826 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To evaluate the impact of patient education on parental stress and illness perception in parents of children with Congenital Heart Disease 
Scientific Title of Study   Effect of patient education on parental stress and illness perception in parents of children with congenital heart disease  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushama Bhandare 
Designation  Assistant Professor  
Affiliation  Seth GS Medical College and KEMH 
Address  Seth GS Medical college Physiotherapy School and Centre Room no 402 Cardiovascular and respiratory department Opposite Tata hospital Parel Mumbai Mumbai MAHARASHTRA India

Mumbai
MAHARASHTRA
400012
India 
Phone  9820219984  
Fax    
Email  sushamab7@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sushama Bhandare 
Designation  Assistant Professor  
Affiliation  Seth GS Medical College and KEMH 
Address  Seth GS Medical college Physiotherapy School and Centre Room no 402 Cardiovascular and respiratory department Opposite Tata hospital Parel Mumbai Mumbai MAHARASHTRA India

Mumbai
MAHARASHTRA
400012
India 
Phone  9820219984  
Fax    
Email  sushamab7@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Shradha Thakur 
Designation  P G Student 
Affiliation  Seth GS Medical College and KEMH 
Address  Seth GS Medical college Physiotherapy School and Centre Room no 402 Cardiovascular and respiratory department Opposite Tata hospital Parel Mumbai Mumbai MAHARASHTRA India

Mumbai
MAHARASHTRA
400012
India 
Phone  7058725042  
Fax    
Email  shraddha.thakur.1599@gmail.com  
 
Source of Monetary or Material Support  
Seth GS Medical College and KEM Hospital Parel east Mumbai 12 
 
Primary Sponsor  
Name  Physiotherapy school and center Seth G S Medcial college and KEMH 
Address  Physiotherapy School and Centre, Department of Cardiology Seth G S Medical college Opposite Tata hospital Parel east Mumbai 12 
Type of Sponsor  Government medical college 
 
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 
DrSushama Bhandare  Physiotherapy School and Centre Seth G S Medical college  Seth GS Medical college Physiotherapy School and Centre Room no 402 Cardiovascular and respiratory department Opposite Tata hospital Parel Mumbai Mumbai MAHARASHTRA India
Mumbai
MAHARASHTRA 		 9820219984

sushamab7@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth G S Medical Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Parents of children with Congenital Heart Disease  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Patient Education  Having a child with congenital heart disease can be very stressful for parents and they often have to face overwhelming emotions. Most often, stress arises from lack of awareness about the diseases condition and a limited understanding of the underlying causes and pathophysiology of the diseases, which can be evaluated on the Brief-Illness perception Questionnaire. Lack of this understanding can lead to stress in parents and subsequently lower a patients adherence to treatment, follow up care and rehabilitation. Parents should be educated about their childs condition, birth defect, option for life saving surgeries and also the potential untreated consequences in the future. Parental education can bridge the gap in understanding regarding the future scope, future treatment plans and the scope of rehabilitation, all aimed at enhancing the quality of life and functional capacity of the child to put back in good lifestyle. However, education will help the patient’s parents to cope up with the challenges and channelize their energy into better caring for their child and future rehabilitation plans. Total duration of this intervention i.e. parental education is 15 minutes. 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  Parents willing to participate.
Parents whose children with CHD are admitted.
Only pre operative children’s parents will be included.
Age of children upto13 years.
Parents who can read Hindi/Marathi/English. 
 
ExclusionCriteria 
Details  Parents of children who are critically ill.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Parental Stress Scale (PSS)
2. Brief Illness Perception Questionnaire (Brief IPQ)  		 Before patient education and immediately after patient education on same day 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="53"
Sample Size from India="53" 
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)   01/08/2024 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Introduction: Congenital heart disease (CHD) is defined as abnormal cardiocirculatory structure or function present at birth.There are studies conducted stating that paediatric surgery, especially heart surgery, is a time of significant stress for parents 2,3 and having a child with congenital heart disease can be very stressful for parents as they often have to face overwhelming emotions and also physical and financial challenges. Between 30% and 80% of parents whose children are diagnosed with CHD have reported facing considerable distress.The anxiety felt by a parent can be transferred to the child and can have an effect on the speed of recovery following paediatric heart surgery. Children rely on the capacity of their parents or caregivers to be educated and adequately care for them since they lack the cognitive and physical abilities to independently care for themselves. Children born with congenital heart disease (CHD) require education specific to their anatomical defect to ensure parents understand the importance of interventions performed as well as medication and equipment management. When parents of children with CHD have a comprehensive understanding of their child’s heart condition, treatment options, and preventive measures against complications, it significantly impacts the child’s health related behaviour. This increased knowledge enhances adherence to treatment while diminishing risky behaviour. Additionally, being well-informed about their child’s care significantly impacts parental stress levels and boosts their confidence in providing adequate care for their child. Offering comprehensive patient education to adequately brief parents about pre-operative, surgical, and post-operative cardiac procedures and plans has been shown to reduce parental anxiety and stress. Studies have proven that providing education and resources related to CHD allows parents to gain an understanding of their child’s cardiac complexities which attributes to reduction in parental stress. Parental education for children with CHD is crucial for enhancing patient prognosis, ensuring better compliance, encouraging post operative follow-up, and facilitating rehabilitation. Patient education offers a valuable platform for parents of children with congenital heart disease to clear their doubts, address their concerns and provide patient centered care. Data specific to education in the CHD population is limited. Nevertheless, research indicates that, education programs improve parental and patient knowledge of their disease and management. The goal of creating this parental education program is twofold: to offer educational resources for parents of children diagnosed with CHD and to assess how it affects their perception of the condition and the levels of stress they experience.
Aim: To evaluate the effect of patient education on parental stress and illness perception in parents of children with Congenital Heart Disease and help parents to cope up with the challenges of ongoing treatment. Objectives: • To evaluate illness perception and score of Parental Stress Scale in parents of children with Congenital Heart Disease. • To assess awareness in parents of children with congenital heart disease. • To compare the effect of patient education on illness perception and score of parental stress scale in parents of children with Congenital Heart Disease. 
Methodology: 1. Participants will be included according to inclusion and exclusion criteria. 2. Participants will be explained about the study. 
3.Collection of demographic data will be done. 
4. Assessment of illness perception of parents of children with Congenital Heart Disease using Brief Illness Perception Questionnaire.
5. Assessment of level of stress experienced by parents of children with Congenital Heart Disease by Parental Stress Scale. 
6. Educate the parents of children with CHD. 
7. Evaluate Illness perception and the score of Parental Stress Scale post education in parents of children with Congenital Heart Disease after the intervention.
 

 
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