Cerebral PalsyNCT04035967
Investigation of Parents' Anxiety Level and Health Related Quality of Life in Different Types of Physical Disabilities
An observational study of Cerebral Palsy and Down Syndrome, run by Sanko University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 24 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Down Syndrome, Spina Bifida
- What is being tested?
- Questionnaire
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Down Syndrome, Spina Bifida, Muscular Dystrophy, Parents
- Being tested
- Questionnaire
- Keywords
- Physical Disabilities, Anxiety Level, Health Related Quality of Life, Parents', cerebral palsy
- Medical subject headings
- Cerebral Palsy, Down Syndrome, Spinal Dysraphism, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called assesment
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: First 1 day
Secondary outcomes (4)
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).
Measured: first 1 day
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.
Measured: first 1 day
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.
Measured: first 1 day
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.
Measured: first 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 May 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adıgüzel, Sanko University
- Investigators
- Hatice Adıgüzel, Principal investigator, Sanko UniversityBülent Elbasan, Ass. Prof., Principal investigator, Gazi UniversityNevin Ergun, Prof., Principal investigator, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035967
- Sponsor's protocol ID
- SankoUni
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Parents' Anxiety Level and Health Related Quality of Life in Different Types of Physical Disabilities
- ClinicalTrials.gov ID
- NCT04035967
- Acronym / sponsor ID
- SankoUni
- Conditions
- Cerebral Palsy, Down Syndrome, Spina Bifida, Muscular Dystrophy, Parents
- Keywords
- Physical Disabilities, Anxiety Level, Health Related Quality of Life, Parents', cerebral palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: assesmentImpact 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) | Other | – |
Primary outcome
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.
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.
4 secondary outcomes
Nottingham Health Profile
Time frame: first 1 day
Impact on family scale
Time frame: first 1 day
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: first 1 day
The Functional Independence Measure for Children (WeeFIM)
Time frame: first 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice Adıgüzel principal investigator
Sanko University
Bülent Elbasan, Ass. Prof. principal investigator
Gazi University
Nevin Ergun, Prof. principal investigator
Sanko University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Down Syndrome, run by Sanko University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI-I) (time frame: first 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.