Empowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach
- Sponsor
- Cukurova University
- Study ID
- NCT07575451
- Status
- Not Yet Recruiting
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Conditions
- Child Development
- Congenital Heart Disease
- Postoperative Care
- Roy Adaptation Model-based Nursing Empowerment Program
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 3 Years
- Healthy Volunteers
- Not accepted
Interventions
- RAM-based Nursing Empowerment Program — BEHAVIORALRAM-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 — OTHERFamilies 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.
Study Details
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.
Key Dates
- First listed
- May 8, 2026
- Start date
- Jun 15, 2026
- Status verified
- May 2026
- Primary completion
- Jun 15, 2027
- Completion
- Jun 15, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Experimental GroupFamilies of children aged 1-3 who participate in the RAM-based nursing empowerment program
- Active Comparator: Control GroupFamilies who receive routine care and the informative booklet
Primary Outcome Measure
Developmental Screening Test II (Denver II) [ Time Frame: At months 1, 2, 3, 6, 9, and 12 after the intervention ]
Central Contacts
- Kübra Türker, PhD Student+905357416538
- Şenay Çetinkaya, Prof. Dr.
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