Cardiovascular DiseasestelconNCT06998186
Discharge Education And Telephone Counseling in Pediatric Cardiac Surgery Patients
A study testing Discharge Education And Telephone Counseling in people with Cardiovascular Diseases and Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 60 days to 6 years
- Conditions the study is for
- Cardiovascular Diseases, Anxiety, Stress
- What is being tested?
- Discharge Education And Telephone Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 days to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Discharge Education And Telephone Counseling in Pediatric Cardiac Surgery Patients
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.
- Conditions
- Cardiovascular Diseases, Anxiety, Stress, Quality of Life, Counselling
- Being tested
- Discharge Education And Telephone Counseling
- Keywords
- pediatric, surgery, telephone counselling, discharge, stress, quality of life
- Medical subject headings
- Cardiovascular Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge Education And Telephone CounselingBehavioural
Providing training on discharge education to parents of cardiac surgery patients.
Providing telephone counseling for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Discharge Education And Telephone Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety with State-Trait Anxiety Inventory
Anxiety assessment with State-Trait Anxiety Inventory by parent
Measured: 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)
Measured: 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
Measured: 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)
Measured: 1st, 3rd and 6th months after the discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jul 2023
- Primary completion18 Sep 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gulcin Ozalp Gerçeker, Assoc. Prof., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998186
- Sponsor's protocol ID
- telcounseling
- Acronym
- telcon
- Status last verified
- May 2025
- First submitted
- 18 Sep 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Discharge Education And Telephone Counseling in Pediatric Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06998186
- Acronym / sponsor ID
- telcon / telcounseling
- Conditions
- Cardiovascular Diseases, Anxiety, Stress, Quality of Life, Counselling
- Keywords
- pediatric, surgery, telephone counselling, discharge, stress, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –standard care. No telephone counselling. |
| Discharge Education And Telephone Counseling | Experimental | Behavioral: Discharge Education And Telephone CounselingDischarge 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) |
Who may qualify
- Ages
- 60 days to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discharge Education And Telephone CounselingProviding training on discharge education to parents of cardiac surgery patients. Providing telephone counseling for 6 months | Behavioural | Discharge Education And Telephone Counseling |
Primary outcome
anxiety with State-Trait Anxiety Inventory
Time frame: 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
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) ]
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
Time frame: 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
1 secondary outcome
Post-Surgery Patient Outcomes
Time frame: 1st, 3rd and 6th months after the discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulcin Ozalp Gerçeker, Assoc. Prof. principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge Education And Telephone Counseling in people with Cardiovascular Diseases and Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety with State-Trait Anxiety Inventory (time frame: change in the State-Trait Anxiety Inventory (baseline-at hospital, 1st, 3rd and 6th months after the discharge) ]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.