Asthma Clinical Trial
Official title:
Quality of Life and Stress in Parents of Children With Developmental Disabilities and Chronic Disease
The aim of this cross-sectional study is to investigate the level of stress and quality of
life in parents of children with developmental disabilities (Down syndrome, autism spectrum
disorder, pervasive developmental disorder, cerebral palsy) and parents of children chronic
diseases (diabetes mellitus type 1, epilepsy, asthma) compared to parents of healthy
children.
The investigators will analyze the level of stress, quality of life, self-esteem, optimism,
resilience, happiness, stigmatization, depression, anxiety, sleep quality, parenting
challenges and some physiological indicators of the stress such as level of cortisol and
heart rate variability. Also, the investigators will measure Advanced Glycation End products
(AGEs) in the skin.
The investigators assume that parents of children with developmental disabilities and chronic
diseases have higher level of stress and lower quality of life compared to the parents of
healthy children.
Participants will be parents of children with a pervasive developmental disorder (autistic
spectrum disorder), Down syndrome, cerebral palsy, epilepsy, diabetes mellitus type 1,
asthma, and parents of healthy children (without difficulty and chronic disease - control
group).
The investigators will examine the level of stress and quality of life in parents of children
with developmental and chronic illnesses, compared to parents of healthy children, adjusting
for the effect of confounding factors.
Data collection will be conducted using the questionnaire to assess personal quality of life,
family quality of life, general and parental stress levels. Additionally, potential
confounding or mediating factors will be measured and taken into account: stress resilience,
cohesion, self-esteem, optimism, perception of happiness, stigmatization, depression,
anxiety, sleep quality and parenting challenges. Also, socio-demographics parameters, short
medical history, lifestyle habits and the perception of life difficulties will be assessed.
The questionnaire will be filled by paper-pencil method with anticipated duration of about 45
minutes.
The investigators will also measure several physiological indicators - salivary cortisol,
heart rate variability, blood pressure and Advanced Glycation End products (AGEs).
Saliva will be taken in order to analyze the cortisol level, using Salivette Sarstedt REF
51.1534.500. Participants will be taken five saliva samples during the day because of the
physiological variability of cortisol (first one around 22:00 hours, second right after
waking up, then 15, 30 and 60 minutes after awaking). Each subject will receive detailed
instructions on how to take saliva, with written instructions. Thirty minutes before
sampling, the subjects has to restrain from eating, drinking, smoking or brushing teeth. In
case of acute illness, inflammation or disease in the oral cavity, the sampling will be
delayed. After taking the sample, tubes will be stored in the refrigerator. In the
laboratory, the sample will be centrifuged for two minutes to remove saliva from cotton, and
saliva samples will be frozen. Cortisol analysis will be done using ECLIA
(Electrochemiluminous Absorption Method).
The electrocardiogram (ECG) will be recorded using the Medilog AR12 Plus Holter device, which
will also be used to record heart rate variability (HRV) during 5 minutes. HRV will also be
recorded using the Polar V800 (also during 5 minutes). Kubios software will be used for HRV
analysis.
AGE Reader, a non-invasive device will be used for measuring the autofluorescence in the
skin, reflecting the level of Advanced Glycation End products (AGEs).
Omrom M6 Comfort is an automatic device which will be used to measure blood pressure and
pulse.
Anthropometric parameters will be measured (body weight, height, neck circumference, waist
and hip circumference).
Statistical analysis will be carried out using statistical program MedCalc. Initial analysis
of results will include analysis of the distribution of variables using the
Kolmogorov-Smirnov test. If the distribution of numerical variables will be normal,
parametric statistics will be applied. The confounding factors will be controlled by using
appropriate statistical tests.
Participation of parents in this study is voluntary. If a parent decides to participate in
this study, the code will be assigned. In that way, all data, measured parameters, and saliva
samples will be encoded, and the personal data of the respondents will be completely
invisible. It will not be possible to identity an individual parent. All researchers must and
will be protecting confidentiality of data.
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