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A Theory-based Sleep Intervention in Improving Sleep Quality in Adolescents

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02551913
Enrollment
2841
Registered
2015-09-16
Start date
2015-09-30
Completion date
2017-04-30
Last updated
2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

Psychological Theory, adolescents

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.

Interventions

BEHAVIORALControl

the adolescents will not receive any specific intervention

BEHAVIORALIntervention

A theory based sleep hygiene intervention based on the theory planned behavior will be conduced on the adolescent

Sponsors

Qazvin University Of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in self-reported Sleep hygiene behaviorchanges from baseline , 1 month and 6 Months follow-upSleep behavior will be assessed through self-report employing 24-h recall of the previous night's sleep
Changes in Sleep durationchanges from baseline , 1 month and 6 Months follow-upSleep 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.

Secondary

MeasureTime frameDescription
General Health Questionnairechanges from baseline , 1 month and 6 Months follow-upA self-administered questionnaire will be given to each participant, in which the PSQI-I, the Iranian version of the General Health Questionnaire 12 (GHQ12-I)
Pediatric Daytime Sleepiness Scalechanges 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-uppsychological predictors of sleep hygiene behavior were assessed using a using a self-reported measure. All items are rated on a Likert-type scale, ranging from 1 to 5.
Changes in health-related quality of lifechanges from baseline , 1 month and 6 Months follow-uphealth-related quality of life will be measured using the Pediatric Quality of Life Inventory™ Short Form 15 Generic Core Scales.
Sleep knowledge questionnairechanges from baseline , 1 month and 6 Months follow-up
Sleep Disturbances Scale for Childrenchanges from baseline , 1 month and 6 Months follow-up
Adolescent Sleep Hygiene Scalechanges from baseline , 1 month and 6 Months follow-up

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026