A Comparison of Sensory and Behavioral Sleep Training in Individuals With Sleep Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
研究概览
简要总结
Sleep problems may affect individuals' daily functioning, emotional well-being, cognitive performance, and quality of life. Non-pharmacological approaches, including sleep hygiene education, sensory-based strategies, and behavioral relaxation techniques, may help individuals develop healthier sleep routines. However, studies directly comparing sensory-based and behavioral approaches are limited.
The aim of this randomized controlled study is to compare the effects of sensory-based and behavioral sleep interventions in adults experiencing poor sleep quality. Participants are randomly assigned to one of three groups: a sleep hygiene education group, a sensory-based intervention group, or a behavioral intervention group. All participants receive a standardized six-week sleep hygiene education program. In addition, the sensory-based intervention group uses aromatherapy and pink noise, while the behavioral intervention group practices progressive muscle relaxation and diaphragmatic breathing exercises.
Participants are assessed before and after the six-week intervention period. The study examines changes in sleep quality and sleep-related behaviors, as well as anxiety, quality of life, activity-role balance, sensory processing characteristics, autonomic nervous system activity, and sleep parameters. The study is expected to provide information about the potential contribution of sensory-based and behavioral strategies to the management of sleep problems.
详细描述
This study is a three-arm, randomized controlled, single-blind trial designed to compare sensory-based and behavioral sleep interventions in individuals with poor sleep quality.
Eligible participants are randomly assigned to one of three parallel groups: a control group receiving standardized sleep hygiene education, a sensory-based intervention group, or a behavioral intervention group. Randomization is performed using a computer-generated random-number sequence. Attention is given to maintaining a balanced distribution of age and sex across the study groups. Because the researcher responsible for delivering the interventions is aware of group allocation, participant and intervention-provider blinding is not feasible. However, study data are coded and analyzed by an independent statistician who is blinded to group allocation.
All participants receive a standardized sleep hygiene education program lasting six weeks. The education addresses behavioral and environmental factors associated with sleep, including maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing exposure to stimulating activities, and arranging the sleep environment in terms of light, noise, and room temperature. Educational content is delivered through an online social media platform and supported by weekly telephone follow-up.
Participants allocated to the sensory-based intervention group receive the sleep hygiene education program together with sensory regulation strategies. These strategies include the inhalation of lavender and orange essential oils before sleep and exposure to pink noise during the transition to sleep. Participants are instructed in the standardized home-based use of these strategies, and adherence is monitored through weekly telephone calls.
Participants allocated to the behavioral intervention group receive the sleep hygiene education program together with progressive muscle relaxation and diaphragmatic breathing exercises. Audio recordings and written instructions are provided to support the standardized home-based practice of these techniques. Adherence is also monitored through weekly telephone calls.
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
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 20 to 55 years
- •Pittsburgh Sleep Quality Index global score of 5 or higher
- •Able to use a smartphone
- •Able to understand and speak Turkish
- •Willing to participate voluntarily and provide informed consent
排除标准
- •History of substance dependence
- •Presence of a chronic physical illness or a diagnosed psychiatric disorder
- •Regular medication use, particularly sleep-regulating medications, antidepressants, or similar medications that may affect sleep
- •Diagnosis of a sleep disorder, such as insomnia or sleep apnea
- •Mini-Mental State Examination score below 24
- •Regular meditation or similar mind-body practice for more than 15 minutes per day
- •Body mass index greater than 34.9 kg/m²
- •Previous participation in a sleep hygiene education program
研究组 & 干预措施
Sleep Hygiene Education Plus Behavioral Intervention
Participants in this group receive the standardized six-week sleep hygiene education program together with a behavioral intervention. The behavioral intervention includes progressive muscle relaxation and diaphragmatic breathing exercises performed before bedtime. Participants receive written instructions and audio recordings to support standardized home-based practice, and adherence is monitored through weekly follow-up telephone calls.
干预措施: Sleep Hygiene Education (Behavioral)
Sleep Hygiene Education Plus Behavioral Intervention
Participants in this group receive the standardized six-week sleep hygiene education program together with a behavioral intervention. The behavioral intervention includes progressive muscle relaxation and diaphragmatic breathing exercises performed before bedtime. Participants receive written instructions and audio recordings to support standardized home-based practice, and adherence is monitored through weekly follow-up telephone calls.
干预措施: Behavioral Relaxation Intervention (Behavioral)
Sleep Hygiene Education
Participants in this group receive a standardized six-week sleep hygiene education program. The program includes recommendations on maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing stimulating activities and screen exposure, and arranging the sleep environment in terms of light, noise, and room temperature. Participants receive weekly follow-up telephone calls to support adherence to the program.
干预措施: Sleep Hygiene Education (Behavioral)
Sleep Hygiene Education Plus Sensory-Based Intervention
Participants in this group receive the standardized six-week sleep hygiene education program together with a sensory-based intervention. The sensory intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants receive standardized instructions for home-based application, and adherence is monitored through weekly follow-up telephone calls.
干预措施: Sleep Hygiene Education (Behavioral)
Sleep Hygiene Education Plus Sensory-Based Intervention
Participants in this group receive the standardized six-week sleep hygiene education program together with a sensory-based intervention. The sensory intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants receive standardized instructions for home-based application, and adherence is monitored through weekly follow-up telephone calls.
干预措施: Sensory-Based Sleep Intervention (Behavioral)
研究者
Zeynep Yazicioglu
Assistant Professor
Atlas University