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

NCT07575451 | Not Yet Recruiting DMC

• 1 other identifier: 154-70
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Condition:Congenital Heart Disease, Postoperative Care, Child Development; Focus: Roy Adaptation Model-based Nursing Empowerment Program

Keywords

Congenital Heart Disease, Cardiac Surgery, Postoperative Care, Nursing Support Program

Outcome Measures

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.

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

Secondary Outcomes (3)

• Parental Self-Efficacy Scale (1-3 Years)

  Month 6 and Month 12 post-intervention

• Child Growth Parameters (Anthropometric Z-Scores)

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

• Feeding Process Maternal Attitude Scale (FPMAS)

  Month 6 and Month 12 post-intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

Families of children aged 1-3 who participate in the RAM-based nursing empowerment program

Behavioral: RAM-based Nursing Empowerment Program

Control Group

ACTIVE COMPARATOR

Families who receive routine care and the informative booklet

Other: Routine Care and Educational Booklet

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (3)

Adana City Training and Research Hospital

Adana, Adana, 01300, Turkey (Türkiye)

Location

Cukurova University

Adana, Adana, 01330, Turkey (Türkiye)

Location

Cukurova University

Adana, Adana, 01330, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  BACKGROUND

• 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. Iranian Journal of Nursing and Midwifery Research. 2015; 20(2):275-281.

  BACKGROUND

• 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.

  BACKGROUND

• Goudarzi F, Khadivzadeh T, Ebadi A, Babazadeh R. Women's interdependence after hysterectomy: a qualitative study based on Roy Adaptation Model. BMC Women's Health. 2022; 22:40.

  BACKGROUND

• Ursavas FE, 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 Nursing. 2021; 44(6): 382-394.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Yalaz K, Anlar B, Bayoglu B. Denver II developmental screening test "Turkish standardization". Ankara: Developmental Child Neurology Association. 2010; 11-26.

  BACKGROUND

• Neyzi O, Gunoz H, Furman A, et al. Reference values for weight, height, head circumference, and body mass index in Turkish children. Cocuk Sagligi ve Hastaliklari Dergisi. 2008; 51:1-14.

  BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Şenay Çetinkaya, Prof. Dr.

  Cukurova University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra Türker, PhD Student

CONTACT

+905357416538; kubrakadah@hotmail.com

Şenay Çetinkaya, Prof. Dr.

CONTACT

scetinkaya@cu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: Arm 1: Experimental Group Arm Type: Experimental Arm Label: Nursing Empowerment Program Group Description: Families of children aged 1-3 years who have undergone cardiac surgery. This group receives a nursing empowerment program based on the Roy Adaptation Model (RAM) consisting of 5 sessions (initial assessment, 4 counseling sessions, and final assessment). Arm 2: Control Group Arm Type: No Intervention (veya "Active Comparator") Arm Label: Routine Care and Booklet Group Description: Families of children aged 1-3 years who have undergone cardiac surgery. This group receives routine hospital follow-ups and an informative booklet based on the Roy Adaptation Model but does not participate in the structured nursing empowerment sessions.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)