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

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Developmental Screening Test II (Denver II) [Time frame: At months 1, 2, 3, 6, 9, and 12 after the intervention]

Secondary outcome measures (3)

• Parental Self-Efficacy Scale (1-3 Years) [Time frame: 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]
• Feeding Process Maternal Attitude Scale (FPMAS) [Time frame: Month 6 and Month 12 post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 3 centers

• Adana City Training and Research Hospital — Adana
• Cukurova University — Adana
• Cukurova University — Adana

Publications

• Demirsoy Horta G, Aksu H, Ozsoy S. Use of Roy's Adaptation Model in women's adaptation to the postpartum period. Ege University Faculty of Nursing Journal (Ege Universitesi Hemsirelik Fakultesi Dergisi). 2017; 33(1):180-190.
• Alimohammadi N, Maleki B, Shahriari M, Chitsaz A. Effect of a care plan based on Roy adaptation model biological dimension on stroke patients' physiologic adaptation level. Iran J Nurs Midwifery Res. 2015 Mar-Apr;20(2):275-81. PMID 25878708
• Uzun S. Sister Callista Roy: Adaptation Model. In: Karadag A, Caliskan N, Baykara ZG (eds). Nursing Theories and Models. Istanbul: Akademi Basin ve Yayincilik. 2017: 382-397.
• Goudarzi F, Khadivzadeh T, Ebadi A, Babazadeh R. Women's interdependence after hysterectomy: a qualitative study based on Roy adaptation model. BMC Womens Health. 2022 Feb 13;22(1):40. doi: 10.1186/s12905-022-01615-2. PMID 35152900
• Erol Ursavas F, Karayurt O. Effects of a Roy's Adaptation Model-Guided Support Group Intervention on Sexual Adjustment, Body Image, and Perceived Social Support in Women With Breast Cancer. Cancer Nurs. 2021 Nov-Dec 01;44(6):E382-E394. doi: 10.1097/NCC.0000000000000854. PMID 32657901
• Elibol F, Magden D, Alpar R. Validity and reliability of the parental self-efficacy scale (1-3 years). Bulletin of Community Medicine (Toplum Hekimligi Bulteni). 2007;26(3):25-31.
• Dilsiz H, Dag I. Feeding Process Maternal Attitude Scale (FPMAS): Development, Validity and Reliability Study. Turk J Pediatr Dis (Turkiye Cocuk Hastaliklari Dergisi). 2020; 14:7-15.
• Yalaz K, Anlar B, Bayoglu B. Denver II developmental screening test "Turkish standardization". Ankara: Developmental Child Neurology Association. 2010; 11-26.

Identifiers

NCT: NCT07575451 · 154-70

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗