The Effects of Mindfulness-Based Stress Reduction Program on the Psychological and Physiological Stress of Family or Caregivers of Children With Motor Disabilities Due to a Neurological Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Perceived Stress
研究概览
简要总结
The present study aims to investigate the effect of a mindfulness-based program on perceived stress, severity of anxiety, parents'/caregivers' quality of life and their children, cortisol and IL-6 blood concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not having attended previously a mindfulness course
- •A score equal to or greater than 23 points at the PSS.
- •>18 years old
- •Children <18y with motor/physical disability due to a Neurological disorder.
- •Spanish/Catalan speaking
排除标准
- •Currently using drugs or any kind of medication related to stress, depression, anxiety or sleeping pills, such as steroid medicines.
- •Regular meditation practice (once a week in the past 12 months)
- •Diagnose of hypertension stage 2
- •Pregnancy in the case of mothers
- •Present hyperthyroidism
- •Primary adrenal insufficiency syndromes such as Cushing syndrome or Addison disease
- •Present any kind of infection or inflammation process, different from the interestingly to the present study that could differ the results
结局指标
主要结局
Perceived Stress
时间窗: baseline, two months (through study completion), and follow-up of one month
To measure participants perceived stress, the Perceived Stress Scale 14 item Spanish version will be used (PSS 14). It consists of 14 items scored from 0 up to 4 (0=never, 1 = rarely 2= sometimes 3= usually 4 =almost always). The total scores on the scale can range from 0 (no stress) to 56 (extreme stress).
Cortisol levels
时间窗: baseline and two months (through study completion)
The cortisol measurement will be sampled with a serum blood test. It is recommended to advise the participants to be fasted. 63 Cortisol levels fluctuate throughout the day, being highest in the morning and lowest at night.63,64 The sample will be collected between 8-9 am to get the highest cortisol.
次要结局
- Severity of clinic anxiety(baseline, two months (through study completion), and follow-up of one month)
- Sleep Quality(baseline, two months (through study completion), and follow-up of one month)
- Quality of Life assessment(baseline, two months (through study completion), and follow-up of one month)
- Blood pressure(baseline, two months (through study completion), and follow-up of one month)
- Resting Heart rate(baseline, two months (through study completion), and follow-up of one month)
- Respiratory rate(baseline, two months (through study completion), and follow-up of one month)
- Interleukin 6 (IL-6)(baseline and two months (through study completion))
研究者
Clàudia Arumí
Principal Investigator
Universitat de Lleida