The Effects of Connective Tissue Massage in Patients With Chronic Insomnia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Insomnia Severity Index Score
研究概览
简要总结
This randomized controlled trial will investigate the effects of connective tissue massage on insomnia severity, objective and subjective sleep outcomes, and stress- and autonomic-related biomarkers in adults with chronic insomnia. Chronic insomnia is a common sleep disorder characterized by persistent difficulties in initiating or maintaining sleep and is associated with impaired daytime functioning, reduced cognitive performance, and diminished quality of life. Non-pharmacological interventions may provide a safe alternative or complementary approach for individuals with chronic insomnia.
A total of 74 adults diagnosed with chronic insomnia by a neurologist and who have not used sleep medication during the previous four weeks will be enrolled. Participants will be randomly allocated to either a connective tissue massage group or a control group. The intervention group will receive 12 sessions of connective tissue massage over a four-week period, with three sessions per week, in addition to sleep hygiene education. The control group will receive sleep hygiene education alone.
Assessments will be performed at baseline and immediately after the four-week intervention period. The primary outcome will be the change in insomnia severity, assessed using the Insomnia Severity Index. Secondary outcomes will include objective sleep parameters recorded by actigraphy over five consecutive days, including total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset. Blood biomarkers associated with hypothalamic-pituitary-adrenal axis activity and autonomic regulation, including cortisol, DHEA-S, alpha-amylase, and oxytocin, will also be assessed. Subjective sleep quality and sleep hygiene will be evaluated using the Pittsburgh Sleep Quality Index and Sleep Hygiene Index, respectively. Adherence to sleep hygiene recommendations will additionally be assessed using sleep diaries.
The study aims to determine whether connective tissue massage combined with sleep hygiene education is more effective than sleep hygiene education alone in reducing insomnia severity and improving objective and subjective sleep outcomes and selected physiological biomarkers in adults with chronic insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Participants will be randomly allocated in a 1:1 ratio to either the connective tissue massage plus sleep hygiene education group or the sleep hygiene education-only control group. Both groups will undergo assessments at baseline and immediately after the four-week intervention period.
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
- 否
入选标准
- •Inclusion Criteria:
- •Adults aged 18 to 65 years, of either sex.
- •Diagnosis of chronic insomnia disorder according to the International -Classification of Sleep Disorders, Third Edition, Turkish version (ICSD-3-TR), established by a neurologist.
- •Difficulty initiating or maintaining sleep occurring at least three nights per week for at least three months, consistent with ICSD-3-TR diagnostic criteria.
- •No use of pharmacological agents for insomnia during the previous four weeks, including benzodiazepines, non-benzodiazepine hypnotics, melatonin and melatonin receptor agonists, sedating antidepressants, and anxiolytics.
- •Insomnia Severity Index score of ≥15, indicating moderate to severe insomnia. Ability to read and write.
- •Standardized Mini-Mental State Examination score of ≥24, indicating adequate cognitive status.
- •Willingness to participate in the study and provision of written informed consent.
排除标准
- •History of shift work during the previous month or lifestyle changes that may disrupt circadian rhythm.
- •Presence of obstructive sleep apnea syndrome, circadian rhythm sleep-wake disorders, or other primary sleep disorders.
- •History of any neurological diagnosis, such as epilepsy or Parkinson's disease, or psychiatric diagnosis, such as depression or bipolar disorder.
- •Presence of an open wound, infection, dermatitis, or other dermatological condition impairing skin integrity in the area where connective tissue massage will be applied.
- •Regular use of medications that may affect sleep, including antidepressants, beta-blockers, or corticosteroids.
- •Initiation of any pharmacological treatment for insomnia, including sleep medications or sedatives, during the four-week study period.
结局指标
主要结局
Change in Insomnia Severity Index Score
时间窗: From baseline to 4 weeks
Change in insomnia severity will be assessed using the Insomnia Severity Index (ISI). Assessments will be performed at baseline and immediately after the four-week intervention period.
次要结局
- Change in Cortisol Level(From baseline to immediately after the 4-week intervention period)
- Change in DHEA-S Level(From baseline to immediately after the 4-week intervention period)
- Change in Alpha-Amylase Level(From baseline to immediately after the 4-week intervention period)
- Change in Oxytocin Level(From baseline to immediately after the 4-week intervention period)
- Change in Total Sleep Time(From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.)
- Change in Sleep Efficiency(From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.)
- Change in Sleep Onset Latency(Sleep onset latency will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep onset latency will be evaluated.)
- Change in Wake After Sleep Onset (WASO)(From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.)
- Change in Number of Nighttime Awakenings(From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.)
- Change in Sleep Fragmentation Index(From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.)
- Change in Pittsburgh Sleep Quality Index Score(From baseline to immediately after the 4-week intervention period)
- Change in Sleep Hygiene Index Score(From baseline to immediately after the 4-week intervention period)