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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorCukurova University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Developmental Screening Test II (Denver II)

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.

Time frame
At months 1, 2, 3, 6, 9, and 12 after the intervention

Secondary outcomes

1

Parental Self-Efficacy Scale (1-3 Years)

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.

Time frame
Month 6 and Month 12 post-intervention
2

Child Growth Parameters (Anthropometric Z-Scores)

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.

Time frame
At months 1, 2, 3, 6, 9, and 12 after the intervention
3

Feeding Process Maternal Attitude Scale (FPMAS)

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.

Time frame
Month 6 and Month 12 post-intervention

Other outcomes

Sponsors and contacts

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