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

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.

• RAM-based Nursing Empowerment Program (Behavioral): 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.
• Routine Care and Educational Booklet (Other): 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.

Primary outcomes

• Developmental Screening Test II (Denver II) [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.

Secondary outcomes

• Parental Self-Efficacy Scale (1-3 Years) [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.
• Child Growth Parameters (Anthropometric Z-Scores) [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.
• Feeding Process Maternal Attitude Scale (FPMAS) [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.

Sex: All, ages: 1 Year to 3 Years

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

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• Şenay Çetinkaya, Prof. Dr., Principal investigator, Cukurova University