Investigation of Parents' Anxiety Level and Health Related Quality of Life in Different Types of Physical Disabilities

NCT04035967 | Completed

• 1 other identifier: SankoUni
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Down Syndrome; Spina Bifida; Muscular Dystrophy; Parents

Keywords

Physical Disabilities; Anxiety Level; Health Related Quality of Life; Parents'; cerebral palsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Nottingham Health Profile

  first 1 day

• Impact on family scale

  first 1 day

• Pediatric Evaluation of Disability Inventory (PEDI)

  first 1 day

• The Functional Independence Measure for Children (WeeFIM)

  first 1 day

Interventions

Questionnaire OTHER

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)

Also known as: assesment

Eligibility Criteria

• Age: 24 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanko University: lead

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Down Syndrome; Spinal Dysraphism; Muscular Dystrophies

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Neural Tube Defects; Nervous System Malformations; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hatice Adıgüzel

  Sanko University

  PRINCIPAL INVESTIGATOR

• Bülent Elbasan, Ass. Prof.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Nevin Ergun, Prof.

  Sanko University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: May 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)