Effect of Educational Program on Parental Stress of Parents of Children With CHD

Study Overview
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Brief Summary
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Congenital Heart disease accounts for about one third of the all congenital anomalies. In last decades' huge advancements occurred in treatment and diagnosis. More and more surgeries are being done which causes stress in parents and affects their mental health. Some studies have reported that about one third of the parents of children with CHD remain in stress even after surgery is being done. The goal of this trial is to evaluate effect of educational intervention on mental health of parents of children with congenital heart disease undergoing cardiac surgery compared to the parents who get usual care and pamphlets of the same information. The investigators are including parents of children with CHD who are already diagnosed with CHD and are undergoing cardiac surgery.

Official Title
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Effect of Educational Program on Parental Stress of Parents of Children With Congenital Heart Disease Undergoing Cardiac Surgery: Quasi Experimental Study

Conditions
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Congenital Heart Defect

Intervention / Treatment
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* Other: psychoeducational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of children with congenital heart disease Patient is scheduled for elective cardiac surgery and not had any surgery before. Willing to participate in the study Exclusion Criteria: Parents of CHD who have other critical conditions along with CHD Parents able to understand local languages (Urdu and Pashto)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (I)<br>Intervention group (I) will be receiving a psychoeducational intervention along with routine care they are getting in the hospital | Other: psychoeducational intervention<br>* . Intervention group (I) will receive psychosocial education which will be consist of two parts. 1) Face to Face 2) Community based intervention. Face to face: This face to face session will be consisting of 30-minute session soon after inclusion into the study. A leaflet consisting of all information will be provided to all the patents taking part in the study. Community Based Intervention: In community based interventions prerecorded videos about all the topics covered in face to face session will be made available to parents via a secure online platform. Parents can easily browse it easily when they need it. These videos will be recorded in local language (Urdu), which is easy to understand for almost all the people.<br>|
| No Intervention: Control group (C)<br>Comparison usual care and Leaflet of the information. At the end of the trial these also get the video and educational sessions as intervention group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental stress in parents of children with congenital Heart disease | Stress changes will be measured via Parental Stress Scale (PSS). The PSS is scored by summing the scores for all 18 items. The total score can range from 18 to 90, with higher scores indicating higher levels of parental stress. The PSS also has two subscales: Child Demandingness (CD) and Parental Competence (PC). PSS scores are interpreted based on the following ranges: 18-37 low stress, 38-56 Moderate stress and 57-90 as high stress. | [Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital]. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on parental QoL | Changes on parental quality of life will be assessed through World Health Organization Quality of Life-Bref (WHOQOL-Bref). The WHOQOL-Bref instrument is composed by 26 items, which are organized in 4 specific domains: Physical (7 items), Psychological (6 items), Social Relationships (3 items), Environment (8 items) and a general QoL facet (2 items). All items are quoted from 1 to 5. Three items, related to questions posed negatively (Q3, Q4 and Q26), must be reversed (the calculation implies the subtraction of their value to six units). The results are transformed on a scale of 0 to 100. Each domain score is computed through the formula: [(sum of all items - number of items) / (4x number of items)] x 100. Higher scores correspond to better quality of life. | [ Time Frame: INTERVENTION group - Baseline (beginning of the study); at 1 day of time of discharge and 12 weeks after intervention. CONTROL group - baseline; at time of discharge and 12 weeks after intervention.] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Heart disease, parental stress