- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035967
Investigation of Parents' Anxiety Level and Health Related Quality of Life in Different Types of Physical Disabilities
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Şehitkamil
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Gaziantep, Şehitkamil, Turkey, 27090
- SANKO University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State-Trait Anxiety Inventory (STAI-I)
Time Frame: first 1 day
|
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).
Time Frame: First 1 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nottingham Health Profile
Time Frame: first 1 day
|
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
|
Impact on family scale
Time Frame: first 1 day
|
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
|
Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: first 1 day
|
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
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The Functional Independence Measure for Children (WeeFIM)
Time Frame: first 1 day
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bülent Elbasan, Ass. Prof., Gazi University
- Principal Investigator: Hatice Adıgüzel, SANKO University
- Principal Investigator: Nevin Ergun, Prof., SANKO University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Brain Damage, Chronic
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Muscular Disorders, Atrophic
- Intellectual Disability
- Nervous System Malformations
- Abnormalities, Multiple
- Chromosome Disorders
- Neural Tube Defects
- Cerebral Palsy
- Muscular Dystrophies
- Down Syndrome
- Spinal Dysraphism
Other Study ID Numbers
- SankoUni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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