NCT06998186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

September 18, 2024

Last Update Submit

May 28, 2025

Conditions

Keywords

pediatricsurgerytelephone counsellingdischargestressquality of life

Outcome Measures

Primary Outcomes (3)

  • anxiety with State-Trait Anxiety Inventory

    Anxiety assessment with State-Trait Anxiety Inventory by parent

    change in the State-Trait Anxiety Inventory (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

    quality of life with World Health Organization Quality of Life Scale Short Form Turkish Version (WHOQOL-BREF-TR)

    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) ]

  • stress with Parental Stress Scale-Short Form

    Stress assessment with Parental Stress Scale-Short Form by parent

    change in the Parental Stress Scale (baseline-at hospital, 1st, 3rd and 6th months after the discharge)

Secondary Outcomes (1)

  • Post-Surgery Patient Outcomes

    1st, 3rd and 6th months after the discharge

Study Arms (2)

Control

NO INTERVENTION

standard care. No telephone counselling.

Discharge Education And Telephone Counseling

EXPERIMENTAL

Discharge and instruction on medication usage Providing training on discharge education to parents of cardiac surgery patients (10-15 minutes on average) (using educational materials on discharge and medications)

Behavioral: Discharge Education And Telephone Counseling

Interventions

Providing training on discharge education to parents of cardiac surgery patients. Providing telephone counseling for 6 months

Discharge Education And Telephone Counseling

Eligibility Criteria

Age60 Days - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalova University

Yalova, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular DiseasesAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Gulcin Ozalp Gerçeker, Assoc. Prof.

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

September 18, 2024

First Posted

May 31, 2025

Study Start

July 1, 2023

Primary Completion

September 18, 2024

Study Completion

May 1, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations