Empowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach

May 8, 2026 updated by: Kübra Türker, Cukurova University

Evaluation of a Nursing Program Based on Roy's Adaptation Model for Empowering Families of Children Aged 1 to 3 Years Post-Cardiac Surgery

The purpose of this clinical trial is to learn about the effects of a nursing support program designed for families of children aged 1 to 3 years who have undergone heart surgery. This program aims to improve parents' caregiving skills and support the healthy growth of their children.

The primary questions the study aims to answer are:

Does the nursing program positively affect the physical growth of children, such as their height and weight?

Does the program improve children's scores on general development tests (Denver II)?

Do parents' attitudes toward child feeding and their confidence in parenting skills increase?

Researchers will divide participants into two groups:

Experimental Group: Families who participate in the nursing education program and receive an informative booklet.

Control Group: Families who only receive an informative booklet and continue with routine hospital follow-ups.

The researchers will compare these two groups to see if participating in the nursing program leads to better results for the children's development and the families' skills.

Participants will be asked to:

Attend 5 different education and counseling sessions, starting one week before surgery and continuing until the child reaches 1 year of follow-up.

Meet with the researcher at specific intervals (at 1, 2, 3, 6, 9, and 12 months) for one year to monitor the child's development (height, weight, head circumference) and skills.

Complete surveys regarding child feeding attitudes and parenting skills at the 6th and 12th month follow-ups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Detailed Description

  1. Study Rationale and Objectives This study is designed as an experimental research project to evaluate the effectiveness of a nursing empowerment program based on Roy's Adaptation Model (RAM). The primary objective is to empower the families of children aged 1 to 3 years who have undergone cardiovascular surgery and to examine the impact of this empowerment on the children's growth, development, and parental outcomes.
  2. Study Design and Setting Design: Prospective, randomized controlled experimental trial.Study Sites: Çukurova University Faculty of Medicine Balcalı Hospital and Adana City Training and Research Hospital (Pediatric Cardiovascular Surgery Departments).Timeframe: June 15, 2026 - June 15, 2027.

  3. Participants and Randomization Universe: All families of children aged 1-3 years undergoing heart surgery at the specified hospitals during the study period.

    Sample Size: Calculated using G*Power 3.1.9.2 (Effect size $f = 0.25$, $\alpha = 0.05$, power $= 0.80$).Randomization: Participants will be assigned to either the Experimental Group or the Control Group using a simple random number table. Homogeneity between groups will be verified via Chi-square and t-tests regarding baseline demographics (age, education, income).

  4. Interventions Experimental Group (Empowerment Program):Families will participate in the "RAM-Based Family Empowerment Program."The program consists of 5 structured sessions:Pre-operative (1 week before): Preparation and baseline assessment.Post-operative (First day in ward): Post-op counseling and support.1st Month Follow-up: First follow-up education session.2nd Month Follow-up: Second follow-up education session.3rd Month Follow-up: Final structured education session.Educational materials include a RAM-based booklet, brochures, and visual aids (videos/posters) focusing on physiological, self-concept, role function, and interdependence modes.Control Group:Families will receive routine hospital care.A "RAM-Based Post-Cardiac Surgery Family Empowerment Booklet" will be provided as a baseline resource, but no structured counseling sessions will be conducted.
  5. Data Collection and Follow-up Schedule All measurements and evaluations throughout the study will be performed face-to-face by the same researcher to ensure data consistency and reliability. The data collection process begins with a Baseline (Pre-operative) assessment conducted one week before surgery, where all tools-including the Sociodemographic and Anthropometric Data Form, the RAM-Based Assessment Form, the Denver II Developmental Screening Test, the Maternal Attitudes Toward Feeding Process Scale (MAFPS), and the Parental Self-Efficacy Scale-are administered to the participants. Following the intervention, a structured follow-up schedule is implemented to monitor the child's physical growth and the family's adaptation process. During the 1st, 2nd, 3rd, and 9th months post-operatively, researchers will perform anthropometric measurements (including height, weight, head circumference, and BMI) and the Denver II test to track developmental progress. At the 6th and 12th-month follow-ups, a comprehensive full assessment will be conducted; this includes a repeat of all anthropometric measurements and the Denver II test, along with the re-administration of the MAFPS for mothers and the Parental Self-Efficacy Scale for both mothers and fathers to evaluate long-term parental outcomes and the sustained effectiveness of the empowerment program.
  6. Pilot Study A pilot study will be conducted with 10 families to test the clarity of the educational content and the duration of data collection tools. Pilot participants will be excluded from the main study analysis.
  7. Statistical Analysis Data will be analyzed using IBM SPSS 28.Descriptive Statistics: Mean, standard deviation, frequency, and percentage.Group Comparisons: Independent t-test or Mann-Whitney U test.Pre-Post Comparisons: Paired t-test or Wilcoxon test.Multi-Factorial Analysis: Repeated Measures ANOVA to evaluate the change over time between groups.Significance Level: $p < 0.05$.
  8. Ethical Considerations Ethical approval has been obtained from the Çukurova University Clinical Research Ethics Committee. Written informed consent will be obtained from all participating families. Confidentiality and anonymity of participant data will be strictly maintained. No physical or psychological risks are anticipated for the participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Adana
      • Adana, Adana, Turkey (Türkiye), 01330
        • Cukurova University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Şenay Çetinkaya, Prof. Dr.
      • Adana, Adana, Turkey (Türkiye), 01300
        • Adana City Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Families who agree to participate in the study and sign the informed consent form.
  • Families of children aged 1-3 years in the preoperative period who are scheduled to undergo cardiac surgery due to congenital heart disease.
  • Families who do not speak or read Turkish but will undergo cardiac surgery due to congenital heart disease will also be included in the study with the assistance of an interpreter.
  • Families who are over 18 years of age and have access to a mobile phone or internet at home.

Exclusion Criteria:

  • Exclusion criteria include the presence of additional congenital malformations, dysmorphic syndromes, chromosomal or endocrine disorders, severe infection, hypothyroidism, or any similar conditions that could lead to growth and developmental delay in the child, alongside congenital heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Families of children aged 1-3 who participate in the RAM-based nursing empowerment program
Behavioral: RAM-based Nursing Empowerment Program
RAM-based nursing empowerment program for families of children (ages 1-3) after heart surgery. Includes 5 structured sessions focusing on family empowerment, coping mechanisms, and child development.
Active Comparator: Control Group
Families who receive routine care and the informative booklet
Other: Routine Care and Educational Booklet
Families in the control group will receive routine care and an educational booklet titled "Family Empowerment Booklet After Cardiac Surgery Based on Roy Adaptation Model". The booklet provides information on care processes and coping strategies.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Developmental Screening Test II (Denver II)
Time Frame: At months 1, 2, 3, 6, 9, and 12 after the intervention
A performance-based test designed to screen children from birth to 72 months for developmental delays. It evaluates 125 items across four domains: Personal-social, fine motor-adaptive, language, and gross motor skills. Results are categorized as Normal, Suspected, or Abnormal based on age-standardized performance.
At months 1, 2, 3, 6, 9, and 12 after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parental Self-Efficacy Scale (1-3 Years)
Time Frame: Month 6 and Month 12 post-intervention
A 51-item scale measuring parental self-efficacy in seven domains: Emotional Competence, Responsive Sensitivity, Protection, Discipline, Play, Teaching, and Daily Routines/Care. Scores range from 51 to 255; higher scores indicate stronger parental self-efficacy.
Month 6 and Month 12 post-intervention
Child Growth Parameters (Anthropometric Z-Scores)
Time Frame: At months 1, 2, 3, 6, 9, and 12 after the intervention
Growth parameters including height, weight, and Body Mass Index (BMI). Standardized Z-scores (Standard Deviation Scores - SDS) will be calculated using WHO Anthro software based on Turkish growth percentiles (Neyzi et al., 2008). Malnutrition is defined as Z-scores below -2 SD.
At months 1, 2, 3, 6, 9, and 12 after the intervention
Feeding Process Maternal Attitude Scale (FPMAS)
Time Frame: Month 6 and Month 12 post-intervention
This 27-item, 5-point Likert-type scale measures maternal attitudes during the feeding process. It includes five sub-dimensions: Negative Mood During Meals, Attitudes Toward Inadequate/Unbalanced Nutrition, Negative Feeding Strategies, Forced Feeding, and Reaction to Others' Opinions. Total scores range from 27 to 135; higher scores indicate more problematic or negative maternal feeding attitudes.
Month 6 and Month 12 post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cukurova University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Şenay Çetinkaya, Prof. Dr., Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 154-70

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect the privacy of participants and due to ethical committee restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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