Quality of Life and Stress in Parents of Children With Developmental Disabilities and Chronic Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 592
- 试验地点
- 2
- 主要终点
- Quality of life in parents of children with developmental disability and chronic disease, and healthy children.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject are parents between 20 and 50 years,
- •subject are parents of the child with developmental disability (Down syndrome, autism spectrum disorder, pervasive developmental disorder, cerebral palsy) or chronic disease (diabetes mellitus type 1, epilepsy, asthma) - the ages of the child between 4 and 12 years.
排除标准
- •severe psychiatry and severe chronic illnesses of parents
- •ischemic heart disease
- •cardiomyopathy
- •heart arrhythmia
- •malignant hypertension
- •diabetic neuropathy
- •transplantation of heart and other organs
- •tetraplegia
- •diseases of the hypothalamus and pituitary and adrenal gland
- •corticosteroid therapy
- •antiarrhythmic therapy
- •therapy of β-blockers
- •therapy of sedatives
- •therapy of anxiolytics
- •chemotherapy
- •night shift work
- •breastfeeding (active or completed within less 6 months)
- •pregnancy
- •diagnose of child less than 6 months
- •parents of children with other severe chronic or rare diseases such as malignant disease, haemophilia, phenylketonuria, neurofibromatosis.
结局指标
主要结局
Quality of life in parents of children with developmental disability and chronic disease, and healthy children.
时间窗: 1 day
Subjects will complete the questionnaires about quality of life. A total 26 item in the WHOQOL-BREF produces four domain scores: physical, psychological, social relationships and environment domain (Likert type scale ranging from 1- strongly disagree to 5 - strongly agree).
Stress in parents of children with developmental disability and chronic disease, and healthy children.
时间窗: 1 days
Subjects will complete the questionnaires about parental stress. Parental Stress Scale consists of 18 item self report scale (Likert type scale ranging from 1-strongly disagree, 2-disagree, 3-undecided, 4-agree 5-strongly agree). Items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood.
次要结局
- Family quality of life(1 day)
- Heart rate variability in parents of children with developmental disability, chronic disease and parents of healthy children(1 day)
- Perceived Stress Scale(1 day)
- Salivary cortisol concentration in parents of children with developmental disability, chronic disease and parents of healthy children.(1 day)
- Advanced glycation end products in parents of children with developmental disability, chronic disease and parents of healthy children.(1 day)
研究者
Ivana Kolcic
MD, PhD, Associate Professor in Epidemiology Centre for Global Health & Department of Public Health Medical School, University of Split
University of Split, School of Medicine