Discharge Education And Telephone Counseling in Pediatric Cardiac Surgery Patients

NCT ID: NCT06998186

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Anxiety Stress Quality of Life Counselling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

standard care. No telephone counselling.

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

Discharge Education And Telephone Counseling

Intervention Type BEHAVIORAL

Providing training on discharge education to parents of cardiac surgery patients.

Providing telephone counseling for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Discharge Education And Telephone Counseling

Providing training on discharge education to parents of cardiac surgery patients.

Providing telephone counseling for 6 months

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Days

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gülçin Özalp Gerçeker

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gulcin Ozalp Gerçeker, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yalova University

Yalova, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

telcounseling

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.