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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04035967
Other study ID # SankoUni
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date May 1, 2019

Study information

Verified date July 2019
Source Sanko University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Years to 70 Years
Eligibility 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

Study Design


Intervention

Other:
Questionnaire
Impact on Family Scale (IPFAM), WeeFIM Pediatric Functional Independence Measurement, Nottingham Health Profile. State-Trait Anxiety Inven¬tory (STAI-I and STAI-II), PEDI (Pediatric Evaulation of Disability Inventory)

Locations

Country Name City State
Turkey Sanko University Gaziantep Sehitkamil

Sponsors (1)

Lead Sponsor Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary State-Trait Anxiety Inventory (STAI-I) It is a well-researched clinical tool for evaluating the current state of anxiety (State-I).A cut-off point of 39-40 typically indicates clinically significant symptoms of a state of anxiety. first 1 day
Primary State-Trait Anxiety Inventory (STAI-II). STAI-II is a well-researched clinical tool for evaluating the tendency towards anxiety. A cut-off point of 39-40 typically indicates clinically significant symptoms of a state of anxiety. First 1 day
Secondary Nottingham Health Profile The NHP is an instrument designed to measure subjective health status containing 38items(answered "yes" or "no") that assess subjective distress in six subgroups:physical mobility (eight items), pain (eight items), sleep (five items), emotional reactions (nine items), social isolation (five items),and energy (three items). Scores for each subgroup range.
from 0 (no problem) to 100 (all problems listed were present).
first 1 day
Secondary Impact on family scale The original objective of the Impact on Family Scale is to assess the effect of a child's illness or health condition on the family. All items had astandard four-point scale ranging from strongly agree to strongly disagree.The four factors measured General Negative Impact (11 items), Disruption of Social Relations (nine items), Coping (four items), and Financial Impact (three items).Items are scored on a Likert scale.A low score indicates a higher impact of the chronic disease on the parents. Scores are calculated as percentages according to the highest scores of each part, using inverse proportion computing. first 1 day
Secondary Pediatric Evaluation of Disability Inventory (PEDI) PEDI as an evaluative tool capable of detecting the presence, extent, and area of a functional delay in children with physical impairment or combined physical and cognitive impairment. The PEDI comprises three content domains: self-care, mobility, and social function. The self-care domain consists of 73 capability items in 15 skill areas. The mobility domain has 59 items across 13 areas and the social functioning has 65 items across 13 areas. Test items are criterion-referenced; a score of one is achieved if the child is capable of performing the activity in most situations. Higher scores shows better functionality. first 1 day
Secondary The Functional Independence Measure for Children (WeeFIM) The WeeFIM was adapted from the adult Functional Independence Measure (FIM), retaining the same structure as the original scale.9 It includes 18 items covering six areas: self-care (eating, grooming, bathing, dressing upper body, dressing lower body, toileting); sphincter control (bladder management, bowel management); transfer (chair / bed / wheelchair transfer, toilet transfer, tub / shower transfer); locomotion (crawling /walking/wheelchair, stair climbing); communication (comprehension, expression); and social cognition (social interaction, problem solving, memory). A 7-level ordinal rating system ranging from 7 (complete independence) to 1 (total assistance), is used to score performance in each item. As with the FIM, the WeeFIM consists of two dimensions: motor and cognitive.The motor scale includes self-care, sphincter control, transfer, and locomotion items; the cognitive scale includes communication, and social cognition items.Higher scores shows better independence. first 1 day
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