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临床试验/NCT02551913
NCT02551913已完成不适用

Effectiveness of Theory-based Sleep Hygiene Intervention in Improving Sleep Quality in Adolescents: a Cluster Randomized Controlled Trial

Qazvin University Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 2,841 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,841
试验地点
1
主要终点
Changes in self-reported Sleep hygiene behavior

研究概览

简要总结

Sleep education has been used as a method of primary and secondary prevention of sleep problems in all age groups. An especially vulnerable age group are adolescents who frequently have poor sleep habits and suffer from sleep deprivation. In adolescents, insufficient sleep, inadequate sleep quality, and irregular sleep patterns are associated with daytime sleepiness, negative moods, increased likelihood of stimulant use, higher levels of risk-taking behavior, poor school performance, and increased risk of unintentional injuries. As an US study has shown, sleepiness was the major causal factor in many traffic accidents and more than 50% of sleep-related crashes involved drivers aged 25 or younger. The study was aimed to evaluate the effectiveness of a theory-based sleep hygiene intervention in improving sleep quality in adolescents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • They are not involved in any sleep education program
  • study at secondary schools in Qazvin city
  • Ability to understand Persian language

排除标准

  • Does not meet inclusion criteria

研究组 & 干预措施

control

Active Comparator

The adolescents will not receive any specific information

干预措施: Control (Behavioral)

Intervention

Experimental

The adolescents will receive relevant information on the importance of adequate sleep, the consequences of sleep deprivation, Provide information about others' approval,Provide normative information about others' behaviour,Goal setting ,action planning, coping planning, Set graded tasks,Prompt self-monitoring of sleep behaviour

干预措施: Intervention (Behavioral)

结局指标

主要结局

Changes in self-reported Sleep hygiene behavior

时间窗: changes from baseline , 1 month and 6 Months follow-up

Sleep behavior will be assessed through self-report employing 24-h recall of the previous night's sleep

Changes in Sleep duration

时间窗: changes from baseline , 1 month and 6 Months follow-up

Sleep duration will be measured using the Pittsburgh Sleep Quality Index (PSIQ). The PSQI is a self-administered questionnaire to assess subjective sleep quality during the previous month (Buysse et al., 1989). The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3): sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbance; use of sleeping medication; and daytime dysfunction.

次要结局

  • Changes in health-related quality of life(changes from baseline , 1 month and 6 Months follow-up)
  • Changes in psychological predictors of sleep hygiene behavior (attitude, subjective norms intention, perceived behavioral control , Self-monitoring, action planning and coping planning)(changes from baseline , 1 month and 6 Months follow-up)
  • Sleep Disturbances Scale for Children(changes from baseline , 1 month and 6 Months follow-up)
  • Sleep knowledge questionnaire(changes from baseline , 1 month and 6 Months follow-up)
  • Adolescent Sleep Hygiene Scale(changes from baseline , 1 month and 6 Months follow-up)
  • General Health Questionnaire(changes from baseline , 1 month and 6 Months follow-up)
  • Pediatric Daytime Sleepiness Scale(changes from baseline , 1 month and 6 Months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir H Pakpour

Associate Professor and Director

Qazvin University Of Medical Sciences

研究点 (1)

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