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

Not Applicable

Not yet recruiting

• Conditions: Congenital Heart Defect
• Interventions: Other: psychoeducational intervention

• Registration Number: NCT06172608
• Lead Sponsor: Zhengzhou University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Study Start: 2024-01-30
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (I)	psychoeducational intervention	Intervention group (I) will be receiving a psychoeducational intervention along with routine care they are getting in the hospital

Primary Outcome Measures

Name	Time	Method
Parental stress in parents of children with congenital Heart disease	[Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital].	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.

Secondary Outcome Measures

Name	Time	Method
Changes on parental QoL	[ 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.]	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.

Trial Locations

Locations (1)

Zhengzhou University,; 🇨🇳 Zhengzhou, Henan, China