跳至主要内容
临床试验/NCT06536218
NCT06536218进行中(未招募)不适用

Effects of Mindfulness Stress Reduction Program on Sleep Status, Stress and Quality of Life in Patients With Sleep Disorders: A Polysomnographic Study

Muş Alparlan University2 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
16
试验地点
2
主要终点
Perceived Stress

研究概览

简要总结

Sleep problems, ranging from mild sleep disturbance to debilitating insomnia, are among the most common health problems occurring in adults, with an estimated prevalence of 35% to 48% (Morin et al., 2009; Mai and Buyss 2008). Insomnia is a fairly common sleep disorder characterized by difficulty falling asleep, difficulty staying asleep, or waking up too early despite adequate sleep opportunity, recurring at least three times a week and accompanied by significant stress or distress during the day (Morin and Jarrin, 2013). ). According to the American guidelines for the treatment of chronic insomnia published in 2017, pharmacotherapy and non-pharmacological treatment are the two main treatment methods for sleep disorders ( Sateia et al., 2017 ).Mindfulness-based stress reduction (MBSR) is an important type of non-pharmacological mindfulness-based intervention that effectively relieves insomnia by decentering (Banno et al., 2019).Regarding the effect of mindfulness intervention in sleep disorders, Ong and Moore suggest that mindfulness can improve sleep by reducing both primary and secondary arousal (Ong and Moore, 2020).Therefore, this study aims to expand the existing investigations by examining whether mindfulness meditation (MBSR) is associated with changes in objectively measured polysomnographic (PSG) sleep profiles of patients with sleep disorders who applied to the Sleep EMG department of Muş State Hospital, and to examine the changes in PSG sleep in the context of a randomized controlled trial. It aims to determine the effect on quality of life by associating it with subjectively reported sleep and stress changes.

详细描述

Sleep problems, ranging from mild sleep disturbance to debilitating insomnia, are among the most common health problems occurring in adults, with an estimated prevalence of 35% to 48% (Morin et al., 2009; Mai and Buyss 2008). Insomnia is a fairly common sleep disorder characterized by difficulty falling asleep, difficulty staying asleep, or waking up too early despite adequate sleep opportunity, recurring at least three times a week and accompanied by significant stress or distress during the day (Morin and Jarrin, 2013). ). According to the American guidelines for the treatment of chronic insomnia published in 2017, pharmacotherapy and non-pharmacological treatment are the two main treatment methods for sleep disorders ( Sateia et al., 2017 ).Mindfulness-based stress reduction (MBSR) is an important type of non-pharmacological mindfulness-based intervention that effectively relieves insomnia by decentering (Banno et al., 2019).Regarding the effect of mindfulness intervention in sleep disorders, Ong and Moore suggest that mindfulness can improve sleep by reducing both primary and secondary arousal (Ong and Moore, 2020).A limited but growing body of evidence suggests that mindfulness and other types of meditation may improve sleep quality. Neuondorf et al., (2015) reviewed 112 research studies of insomnia or sleep disturbance testing a variety of different mind-body interventions, including meditation, and found that although the evidence was heterogeneous, limited, and potentially biased, mind-body training was a treatment option for patients. It has been shown that it can be accepted as (Neuendorf et al., 2015). A recent systematic review and meta-analysis focused on identifying and evaluating the clinical significance of different mindfulness-based interventions (MBI) on sleep in individuals with anxiety and depression, showing significant effects on sleep problem improvement across all MBI programs (Chan et al. al., 2022) .Therefore, this study aims to expand the existing investigations by examining whether mindfulness meditation (MBSR) is associated with changes in objectively measured polysomnographic (PSG) sleep profiles of patients with sleep disorders who applied to the Sleep EMG department of Muş State Hospital, and to examine the changes in PSG sleep in the context of a randomized controlled trial. It aims to determine the effect on quality of life by associating it with subjectively reported sleep and stress changes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

盲法说明

Control Group; It is planned to conduct a one-session (60-minute), unstructured, active participation-based group application (the week when the first session is applied to the intervention group) in which participants share their experiences with each other about stress and stressful experiences.

Intervention Group: Conscious Awareness Based Stress Reduction (BFTSA) intervention consists of seven sessions in total and is planned to be completed in a total of seven weeks, with one session per week and each session being 45 minutes. After the results of the patients who underwent PSG are determined according to the randomization criteria and receive certain points from the sleep scale, it is planned to call the patients by phone and explain the meaning and importance of the study, the applications to be performed in the study and its duration. It is planned to have an online individual interview with patients who agree to participate in this study.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between the ages of 18-65
  • Knowing how to read and write
  • Being able to speak Turkish fluently
  • Being diagnosed with a sleep disorder as a result of Polysomnography

排除标准

  • • Being diagnosed with any mental illness
  • Using any psychotropic medication
  • Having a chronic disease that prevents you from doing exercises
  • Participating in any awareness-based training program in the last year
  • Being diagnosed with obstructive sleep apnea syndrome (OSAS)
  • Being diagnosed with narcolepsy
  • Randomization Criteria In this study, individuals;
  • Sleep quality scale score,
  • Perceived Stress Scale score
  • Will be randomized according to quality of life scale scores.

结局指标

主要结局

Perceived Stress

时间窗: 11 WEEKS

Mindfulness Stress Reduction Program Affects the perceived stress level of patients with sleep disorders

Life quality

时间窗: 11 WEEKS

Conscious Awareness Stress Reduction Program affects the quality of life of patients with sleep disorders.

Sleep Status

时间窗: 11 WEEKS

Conscious Awareness Stress Reduction Program does not affect the sleep status of patients with sleep disorders.

次要结局

未报告次要终点

研究者

发起方
Muş Alparlan University
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验