Clinical trial NCT02551913: A Theory-based Sleep Intervention in Improving Sleep Quality in Adolescents
Official title: Effectiveness of Theory-based Sleep Hygiene Intervention in Improving Sleep Quality in Adolescents: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Psychological Theory
adolescents
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 2841
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: Changes in self-reported Sleep hygiene behavior
timeFrame: changes from baseline , 1 month and 6 Months follow-up
measure: Changes in Sleep duration
timeFrame: changes from baseline , 1 month and 6 Months follow-up
Secondary outcomes:
measure: Changes in psychological predictors of sleep hygiene behavior (attitude, subjective norms intention, perceived behavioral control , Self-monitoring, action planning and coping planning)
timeFrame: changes from baseline , 1 month and 6 Months follow-up
measure: Adolescent Sleep Hygiene Scale
timeFrame: changes from baseline , 1 month and 6 Months follow-up
measure: General Health Questionnaire
timeFrame: changes from baseline , 1 month and 6 Months follow-up
measure: Pediatric Daytime Sleepiness Scale
timeFrame: changes from baseline , 1 month and 6 Months follow-up
measure: Sleep Disturbances Scale for Children
timeFrame: changes from baseline , 1 month and 6 Months follow-up
measure: Changes in health-related quality of life
timeFrame: changes from baseline , 1 month and 6 Months follow-up
measure: Sleep knowledge questionnaire
timeFrame: changes from baseline , 1 month and 6 Months follow-up
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: The Organization for Education
Study officials:
References:
citation: Lin CY, Strong C, Scott AJ, Brostrom A, Pakpour AH, Webb TL. A cluster randomized controlled trial of a theory-based sleep hygiene intervention for adolescents. Sleep. 2018 Nov 1;41(11). doi: 10.1093/sleep/zsy170.