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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Defect
• Intervention / Treatment: Other: psychoeducational intervention

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HAMAYUN KHAN; Phone Number: 16638144502; Email: hamayunkhn1@gmail.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Zhengzhou University,
      • Contact: Zhang Wei Hong, PhD; Phone Number: 18638127788; Email: zwhong306@zzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Parents of children with congenital heart disease
2. Patient is scheduled for elective cardiac surgery and not had any surgery before.
3. Willing to participate in the study

Exclusion Criteria:

1. Parents of CHD who have other critical conditions along with CHD
2. Parents able to understand local languages (Urdu and Pashto)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (I); Intervention group (I) will be receiving a psychoeducational intervention along with routine care they are getting in the hospital	Other: psychoeducational intervention; . 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.
No Intervention: Control group (C); 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?

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.]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression in parents of children with CHD	Depression in parents of children with CHD will be assessed through DASS. The Depression Anxiety Stress Scales (DASS) is a self-report questionnaire that assesses the three most common negative emotional states: depression, anxiety, and stress. It is a widely used tool in research and clinical settings to measure these symptoms and their impact on an individual's well-being. Each item on the DASS is rated on a 4-point Likert scale, ranging from 0 (never) to 3 (almost always). The total score for each subscale is calculated by summing the scores for the items on that subscale. Higher scores on each subscale indicate more severe symptoms.	[Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital]
Anxiety in parents of children with CHD	Anxiety in parents of children with CHD will be assessed through DASS. The Depression Anxiety Stress Scales (DASS) is a self-report questionnaire that assesses the three most common negative emotional states: depression, anxiety, and stress. It is a widely used tool in research and clinical settings to measure these symptoms and their impact on an individual's well-being. Each item on the DASS is rated on a 4-point Likert scale, ranging from 0 (never) to 3 (almost always). The total score for each subscale is calculated by summing the scores for the items on that subscale. Higher scores on each subscale indicate more severe symptoms.	[Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital]

Collaborators and Investigators

• Sponsor: Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Congenital Heart disease, parental stress
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: 2023-296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No