Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation

NCT ID: NCT07055334

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2026-12-31

Brief Summary

This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.

Conditions

Heart Defects, Congenital; Rehabilitation; Preschool Child; Qualitative Research; Caregivers; Medical Staff, Hospital

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age 3 to 7 years
• Clinical diagnosis of congenital heart disease
• Underwent a single open-heart surgical correction under direct vision at the study site
• Ability to communicate in Chinese

• Primary caregiver who voluntarily provides care
• Caregiver who spends the most time with the child
• Ability to communicate in Chinese

• Licensed healthcare professionals, including physicians, nurses, dietitians, physical therapists, or psychological counselors
• At least 5 years of professional experience in congenital heart disease care, rehabilitation, or education

Exclusion Criteria

• Postoperative arrhythmia
• Comorbid neurological, respiratory, or other systemic diseases
• Deemed unsuitable for exercise by a physician
• Cardiac function classified as NYHA Class IV
• Intellectual, language, or motor impairments resulting from perioperative complications or other causes

Caregivers of Children With Congenital Heart Disease After Surgery

• Caregivers of children who voluntarily discontinued treatment before completion
• Paid or professional caregivers
• Diagnosed cognitive impairment or mental illness
• Inability to communicate effectively through spoken language
• Presence of serious conflict or instability in the caregiver-child relationship
• Inability to independently operate or use smart electronic devices and the internet

Medical Professionals Involved in Congenital Heart Disease Care

• Not currently engaged in frontline clinical work
• Not engaged in clinical work within the past year due to leave, study, or reassignment

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wei XIA, PhD

OTHER

Sponsor Role: lead

Responsible Party

Wei XIA, PhD

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xia Wei, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Xia Wei, PhD

Role: CONTACT

xiaw23@mail.sysu.edu.cn

+8618823359471

Luo Cong, Master

Role: CONTACT

luoc3@mail.sysu.edu.cn

+8619731525206

Other Identifiers

LSLL2024-801

Identifier Type: -

Identifier Source: org_study_id