Clinical trial NCT04035967: Investigation of Parents' Anxiety Level and Health Related Quality of Life in Different Types of Physical Disabilities
Official title: Investigation of Parents' Anxiety Level and Health Related Quality of Life in Different Types of Physical Disabilities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Down Syndrome
Spina Bifida
Muscular Dystrophy
Parents
Keywords: Physical Disabilities
Anxiety Level
Health Related Quality of Life
Parents'
cerebral palsy
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 91
Sex: ALL
Minimum age (years): 24
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mothers of 80 cerebral palsy (SP), spina bifida (SP), muscular dystrophy (Duchenne muscular dystrophy (DMD), spinal muscular atrophy (SMA), Becker Muscular Dystrophy (BMD), Down Syndrome will be included.Also mothers of 20 healthy children will be included.

Brief summary: Disability brings many psychosocial problems in society. The effects of the health of a disabled child on the psychological health and quality of life of the family are inevitable. It has been shown that families with disabled children are exposed to chronic stress, have communication problems and social isolation between parents, and have to spend extra time for the care of children. It is reported in the literature that parents with mentally or physically handicapped children are more stressed and have higher levels of anxiety than parents without children with disabilities. Since activity limitations, participation restrictions, and social and physical barriers are different in each disability group, caregivers may be affected differently. Comparing the quality of life of caregivers of different disability groups and guiding the family in line with the results obtained is important for public health.As the time spent on care may vary in different types of disability, families' levels of distress and anxiety may also be different.There are no studies in the literature comparing the anxiety level of the parents of the individuals with Muscular Dystrophy (MD), Spina Bifida (SB), Cerebral Palsy (SP) and Down Syndrome (DS), which have a very important place in the permanent disability groups, by evaluating the family effect levels and health-related quality of life. . For this reason, this study was planned to investigate the quality of life, anxiety, level of disease and social effects of mothers with different physical disabilities.

Detailed description: Disability is a life-long condition that involves different care needs and includes many psychosocial problems. Having a disabled child is for all family members; creates stress. In the studies, it was found that mothers with disabled children were more stressed and their anxiety levels were higher. There are many disabled people in Turkey and researches related to the caregiver, although there is not enough research on these people. Since activity limitations, participation restrictions and social and physical barriers are different in each disability group, caregivers' influences may also be different. Comparing the quality of life of caregivers of different disability groups and guiding the family in line with the results obtained is important for public health. It is known that the mothers of children with physical disabilities have more symptoms of depression depending on the functional levels of the children. The severity of depression was also found to be higher in people with physical disabilities than other disability groups. In addition, it has been shown that there is a positive relationship between the time spent on care of the child and the level of strain of caregivers. As the time spent on care may vary in different types of disability, families' levels of distress and anxiety may also be different. This is the rehabilitation services; In addition to the physiotherapy applied to physically disabled individuals, it is thought that the social needs of caregivers should be determined and met.In the literature, there are no studies comparing the effects of disease, anxiety levels and quality of life of parents with Muscular Dystrophy (MD), Spina Bifida (SB), Cerebral Palsy (SP) and Down Syndrome (DS). This study was planned to investigate the quality of life, anxiety level, family effects and social effects of the mothers with different physical disabilities.

Eligibility criteria: Inclusion Criteria:

* Literate mothers with physical disabilities or healthy children between the ages of 4 and 16, without any known functional and psychological problems
* Literate mothers aged 4-16 years with healthy children, without any known functional and psychological problems
* Signed informed consent form

Exclusion Criteria:

* Mothers of 20 healthy children will be included. with the children who have multiple disabilities
* Mothers of 20 healthy children will be included. with the children who have severe / moderate mental impairment
* Mothers of 20 healthy children will be included. with the children who have Down's syndrome or autism

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI-I)
timeFrame: first 1 day
measure: State-Trait Anxiety Inventory (STAI-II).
timeFrame: First 1 day
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: first 1 day
measure: Impact on family scale
timeFrame: first 1 day
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: first 1 day
measure: The Functional Independence Measure for Children (WeeFIM)
timeFrame: first 1 day
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Sanko University
state: Şehitkamil
Study officials:
affiliation: Sanko University
name: Hatice Adıgüzel
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Bülent Elbasan, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanko University
name: Nevin Ergun, Prof.
role: PRINCIPAL_INVESTIGATOR
References: