Discharge Education And Telephone Counseling in Pediatric Cardiac Surgery Patients

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Anxiety; Stress; Quality of Life; Counselling

• Registration Number: NCT06998186
• Lead Sponsor: Dokuz Eylul University

Brief Summary

It was aimed to evaluate the effect of discharge education and telephone counselling applied to parents of 0-6 years old pediatric cardiac surgery patients on postoperative patient outcomes, quality of life, anxiety, and stress levels of parents.

Detailed Description

H0: Discharge education and telephone counselling applied to parents of paediatric cardiac surgery patients has no effect on postoperative patient outcomes (weight gain, tachypnoea/cyanosis/chest pain, increase in activity, complication status), parents' anxiety, stress and quality of life.

H1: Discharge education and telephone counselling applied to parents of paediatric cardiac surgery patients have an effect on postoperative patient outcomes (weight gain, tachypnoea/cyanosis/chest pain, increase in activity, complication status), parents' anxiety, stress and quality of life.

Data Collection:

After the child and his family are informed about the study, their written informed consent will be obtained. According to the randomisation scheme, patients will be divided into experimental and control groups by stratified randomisation method.

The parents of the patients in the study group will get pre-discharge education. The clinic's routine will continue for the children in the control group, and they won't receive any training. The researcher will conduct a telephone consultation to assess the outcomes of the patients in both groups, as well as the parents' quality of life, anxiety, and stress levels.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-09-18
• Study First Submitted: 2024-09-18
• Status Verified: 2025-05
• Study Completion: 2025-05-01
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• The child's age ranges from 0 to 6 years old.
• Possessing congenital heart disease
• Planning for pediatric heart surgery
• Receiving inpatient care;
• Receiving a recent diagnosis and beginning therapy
• The parent willingly consents to participate in the study;
• There isn't another child in the family who has CHD.
• Getting the parent's consent on paper

Exclusion Criteria

• Suffering from another illness
• The child is nearing the end of their life.
• The child and family have expressed a lack of willingness to engage in the study.
• Illiteracy of the parents
• The child and family do not know Turkish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
anxiety with State-Trait Anxiety Inventory	change in the State-Trait Anxiety Inventory (baseline-at hospital, 1st, 3rd and 6th months after the discharge) ]	Anxiety assessment with State-Trait Anxiety Inventory by parent
quality of life with World Health Organization Quality of Life Scale Short Form Turkish Version	change in the World Health Organization Quality of Life Scale Short Form Turkish Version (WHOQOL-BREF-TR) (baseline-at hospital, 1st, 3rd and 6th months after the discharge) ]	quality of life with World Health Organization Quality of Life Scale Short Form Turkish Version (WHOQOL-BREF-TR)
stress with Parental Stress Scale-Short Form	change in the Parental Stress Scale (baseline-at hospital, 1st, 3rd and 6th months after the discharge)	Stress assessment with Parental Stress Scale-Short Form by parent

Secondary Outcome Measures

Name	Time	Method
Post-Surgery Patient Outcomes	1st, 3rd and 6th months after the discharge	change in health status, physical problems, physical symptoms, if any, adaptation to normal life, problems experienced, etc. besides regarding nutrition, breastfeeding, weight gain, oxygen saturation, pulse, respiration, pain, cleaning/bathing, wound healing, presence of infection, neurodevelopmental and motor behaviors, activity level, and medications after the discharge)

Trial Locations

Locations (1)

Yalova University; 🇹🇷 Yalova, Turkey