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NCT Number: NCT02551913

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

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.

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Key information

Conditions

Sleep

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Organization for Education

Qazvin, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Behavioral

the adolescents will not receive any specific intervention

Intervention

Behavioral

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

Primary outcomes

  1. Changes in self-reported Sleep hygiene behavior

    Time frame: 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

  2. Changes in Sleep duration

    Time frame: 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.

Secondary outcomes

  1. Changes in psychological predictors of sleep hygiene behavior (attitude, subjective norms intention, perceived behavioral control , Self-monitoring, action planning and coping planning)

    Time frame: changes from baseline , 1 month and 6 Months follow-up

    psychological 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.

  2. Adolescent Sleep Hygiene Scale

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  3. General Health Questionnaire

    Time frame: changes from baseline , 1 month and 6 Months follow-up

    A 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)

  4. Pediatric Daytime Sleepiness Scale

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  5. Sleep Disturbances Scale for Children

    Time frame: changes from baseline , 1 month and 6 Months follow-up

  6. Changes in health-related quality of life

    Time frame: changes from baseline , 1 month and 6 Months follow-up

    health-related quality of life will be measured using the Pediatric Quality of Life Inventory™ Short Form 15 Generic Core Scales.

  7. Sleep knowledge questionnaire

    Time frame: changes from baseline , 1 month and 6 Months follow-up

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 16, 2015
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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