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

NCT06172608 | Unknown DMC

• 1 other identifier: 2023-296
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Defect

Keywords

Congenital Heart disease, parental stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.]

Other Outcomes (2)

• Depression in parents of children with CHD

  [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

  [Time Frame: INTERVENTION group (I) Baseline (beginning of the study); at 1 day of discharge time and 12 weeks after discharge from hospital]

Study Arms (2)

Intervention Group (I)

EXPERIMENTAL

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

Other: psychoeducational intervention

Control group (C)

NO INTERVENTION

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.

Interventions

psychoeducational intervention OTHER

. Intervention group (I) will receive psychosocial education which will be consist of two parts. 1) Face to Face 2) Community based intervention. 1. 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. 2. 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.

Intervention Group (I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

Zhengzhou University,

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

HAMAYUN KHAN

CONTACT

16638144502; hamayunkhn1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 15, 2023
• Study Start: January 30, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)