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CompletedNCT06998186telconUpdated May 31, 2025

Discharge Education And Telephone Counseling in Pediatric Cardiac Surgery Patients

An interventional study of Discharge Education And Telephone Counseling in Cardiovascular Diseases, Anxiety and Stress, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 60 Days to 6 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jul 2023, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
60 Days to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Anxiety
  • Stress
  • Quality of Life
  • Counselling

Keywords

  • pediatric
  • surgery
  • telephone counselling
  • discharge
  • stress
  • quality of life
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 54 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 257 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Days to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
54 participants (actual)

Study arms

  • No intervention
    Control

    standard care. No telephone counselling.

  • Experimental
    Discharge Education And Telephone Counseling

    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

  • BehavioralDischarge Education And Telephone Counseling

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

06

What researchers measure

Primary outcomes

  1. anxiety with State-Trait Anxiety Inventory

    Anxiety assessment with State-Trait Anxiety Inventory by parent

    Time frame: change in the State-Trait Anxiety Inventory (baseline-at hospital, 1st, 3rd and 6th months after the discharge) ]

  2. 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)

    Time frame: 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) ]

  3. stress with Parental Stress Scale-Short Form

    Stress assessment with Parental Stress Scale-Short Form by parent

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

Secondary outcomes

  1. Post-Surgery Patient Outcomes

    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)

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

07

Study locations

1 site
  • Yalova University
    Yalova, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06998186
Responsible party
Gülçin Özalp Gerçeker (Assoc. Prof., Dokuz Eylul University) — Principal investigator
First posted
May 31, 2025
Start date
Jul 1, 2023
Primary completion
Sep 18, 2024
Completion
May 1, 2025
Last update
May 31, 2025

Study contacts

Gulcin Ozalp Gerçeker, Assoc. Prof.
principal investigator · Dokuz Eylul University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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