Bedtime Routines and Health-related Outcomes in School-age Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- the change of bedtime activities and sleep patterns
研究概览
简要总结
In Taiwan, the prevalence of sleep problems, myopia, and dental caries in school-age children is high. Little is known regarding the implementation of oral and vision health outcomes around bedtime. A bedtime routine intervention was conducted to improve children's oral, vision and sleep health.
详细描述
Background: In Taiwan, the prevalence of sleep problems, myopia, and dental caries in school-age children is high. Recent studies show that there are some linkages between sleep, myopia, and dental caries; however, most of the studies were observational studies and lack of interventional studies. In addition, little is known regarding the implementation of oral and vision health outcomes around bedtime. Establishing beneficial bedtime routines is recommended for improving health-related outcomes. Brush-Book-Bed (BBB), a bedtime routine program proposed by the American Academy of Pediatrics, has been widely applied in Western countries as a bedtime guideline. Therefore, in current research, researchers will apply the concept of BBB into practice with primary caregivers with the hope to improve sleep, dental health, and vision health outcomes.
Purpose: To compare the effectiveness of a BBB intervention group to control groups in school-age children.
Method: This study is a pilot interventional study. A total of 200 first graders will be allocated to either the intervention group or the control group. Inclusion criteria include (1) sleep duration less than 9 hours or more than 11 hours (2) average bedtime later than 9:30 p.m. Exclusion criteria include (1) intellectual disability prior to pre-school age diagnosed by physicians (2) special education students (3) less than 15 school day per month (4) medications used that influence sleep (5) congenital eye diseases (6) dental emergencies. Individual permuted block randomization will be used for the assignment. Intervention includes bedtime brushing, limited sugar consumption around bedtime, reading books instead of using screen devices before bed, setting a regular bedtime, turning off the light, and reaching a 9 to 11-hour sleep duration. Researchers will send interactive reminder messages periodically to maintain participants' compliance. Sleep questionnaires include CSHQ, modified Bedtime Routine Questionnaires, a sleep diary, Pediatric Daytime Sleepiness Scale, Questionnaire, Epworth Sleepiness Scale, and The Pittsburgh Sleep Quality Index. Oral hygiene evaluation includes salivary pH value and salivary flow rate. The near vision test and refractive error are evaluated as myopia measurements. Asthenopia pictures and critical flicker fusion frequency are used to measure subjective eye fatigue. Moreover, a self-administered questionnaire related to sleep, oral hygiene, and vision health is also measured. Intervention Feasibility will be asked with open-ended questionnaires immediately after the intervention. Data analyses will be conducted using SPSS Statistics 22.0. The findings of this pilot study will provide the basis for developing a tailored bedtime routine for Taiwanese children. which can be applied in further interventional studies. In addition, outcome indicators can act as proxies, early detection if potential risks of sleep problems, and vision or oral diseases.
Estimated Result: School-age children who receive BBB intervention will have significantly better health-related outcomes than those without after the intervention, the third and sixth months post-intervention.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children whose average bedtime later than 9:30 pm
- •Children who sleep less than 9 hours or more than 11 hours
排除标准
- •intellectual disability prior to pre-school age diagnosed by physicians
- •special education students
- •less than 15 school day per month
- •medications used that influence sleep
- •congenital eye diseases
- •dental emergencies
结局指标
主要结局
the change of bedtime activities and sleep patterns
时间窗: 7 days at baseline, three month post intervention and six month post intervention
self-administered sleep diary, including sleep patterns, screen device use 2 hours before bedtime, caffine food intake
the change of bedtime routines
时间窗: baseline, three month post intervention and six month post intervention
Bedtime routine questionnaire (Handerson \& Jordan, 2010): the subscale of bedtime consistency and bedtime adaptive activities
the change of children's sleep habits
时间窗: three month post intervention and six month post intervention
Children's sleep habits questionnaire, CSHQ (Owens et al., 2000). Higher score means more disturbed sleep. The internal consistency for both the community sample was 0.68; alpha coefficients for the various subscales of the CSHQ ranged from 0.36 (Parasomnias) to 0.70 (Bedtime Resistance) for the community sample. Test-retest reliability was acceptable (range 0.62 to 0.79).
The change of caregiver's sleep quality
时间窗: baseline, three month post intervention and six month post intervention
Pittsburgh Sleep Quality Index, PSQI (Buysse et al., 1989). The global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p less than 0.001) in distinguishing good and poor sleepers.
The change of caregiver's daytime sleepiness
时间窗: baseline, three month post intervention and six month post intervention
Epworth Sleepiness Scale, ESS (Johns et al., 1991). The internal consistency as measured by Cronbach's alpha was 0.88. Higher scores means more daytimes sleepiness.
The change of pediatric daytime sleepiness
时间窗: baseline, three month post intervention and six month post intervention
Pediatric Daytime Sleepiness (Drake et al., 2003). Scores ranged from 0 to 32. Mean score values in the original study were 15.3 ± 6.2. Higher scores indicate greater sleepiness.
次要结局
- the change of myopia(baseline, three month post intervention and six month post intervention)
- the change of stereopsis(baseline, three month post intervention and six month post intervention)
- the change of objective Asthenopia(baseline, three month post intervention and six month post intervention)
- the change of subjective Asthnopia(baseline, three month post intervention and six month post intervention)
- the change of oral pH(baseline, three month post intervention and six month post intervention; before bedtime after brushing and rising time before brushing)
- the change of salivary flow rate(baseline, three month post intervention and six month post intervention)
- the change of health-related cognition(baseline, three month post intervention and six month post intervention)
研究者
Han-Yi Tsai
National Taiwan University
National Taiwan University