Clinical trial NCT06224322: Caregiver Burden in Cerebral Palsy Undergoing Hip and Knee Surgery
Official title: Evaluation of Factors Affecting Caregiver Burden in Cerebral Palsy Patients Undergoing Hip and Knee Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Care Giving Burden
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study will be conducted with the parents of children with cerebral palsy who are admitted to the Orthopaedics Unit of Istanbul Medical Faculty and will be operated on in the knee-hip region.

Brief summary: The aim of this observational study was to obtain information about the change in the burden of care of parents of children with cerebral palsy after hip and knee surgeries. The main questions it aims to answer are:

Q1-Does caregiver burden change after hip and knee surgeries? Q2-If so, which factors contribute more positively to this situation? Participants will be asked to answer the scales given to them periodically before and after the surgery.

Detailed description: One of the most common causes of disability in childhood is cerebral palsy, which develops due to damage to the central nervous system. Children diagnosed with cerebral palsy face different problems in every period of their lives. The child, his/her family and the society he/she lives in should be considered as a whole. There is a mechanism that mutually affects each other.

Parenting, caring for and living with a child with cerebral palsy can have many negative effects on the lives of parents and create additional burdens for them. Parents may have to choose between their own needs, the needs of other members of the family and the needs of the child with cerebral palsy, and may spend most of their time with their disabled child. This can negatively affect the burden, stress level, physical activity level, quality of life, psychological status and self-efficacy perception.

The primary aim of this study is to evaluate the caregiver burden in Cerebral Palsy, which is the most common cause of morbidity in the pediatric age group in orthopedics, and to analyze the factors that negatively affect it. Our hypothesis is that the functional mobilization status of patients will increase, especially as a result of hip surgeries, reducing caregiver burden.

Eligibility criteria: Inclusion Criteria:

1. Parent Age

   a. Being in the 20-60 age group.
2. Diagnosis

   1. Having a child with clinically diagnosed cerebral palsy
   2. The movement scale of the cerebral palsy patient is between GMFS 3 and 5
3. A minimum follow-up of 12 months after surgery
4. The primary carer is the mother or father

Exclusion Criteria:

1. The patient and his/her family have been lost to follow-up
2. Having another disabled person in need of care in the family
3. Family's unwillingness to participate in the study
4. Loss of a parent

Primary outcomes:
measure: Zarit Caregiven Burden scale
timeFrame: Preoperative, Postoperative three, six and twelve month
Secondary outcomes:
measure: Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module
timeFrame: Preoperative, Postoperative three, six and twelve month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey
state: Fatih-Topkapı
city: Istanbul
country: Turkey
facility: Istanbul Unıversity Medicine Faculty Orthopaedic Department
state: Fatih
Study officials:
affiliation: Assistant Professor
name: Mehmet MD Demirel, MD
role: PRINCIPAL_INVESTIGATOR
References: