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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551913
• Other study ID #: QUMS398
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: February 8, 2018
• Start date: September 2015
• Est. completion date: April 2017

Study information

• Verified date: February 2018
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2841
• Est. completion date: April 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Control
the adolescents will not receive any specific intervention
• Intervention
A theory based sleep hygiene intervention based on the theory planned behavior will be conduced on the adolescent

Locations

Country	Name	City	State
Iran, Islamic Republic of	The Organization for Education	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in self-reported Sleep hygiene behavior	Sleep behavior will be assessed through self-report employing 24-h recall of the previous night's sleep	changes from baseline , 1 month and 6 Months follow-up
Primary	Changes in Sleep duration	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.	changes from baseline , 1 month and 6 Months follow-up
Secondary	Changes in psychological predictors of sleep hygiene behavior (attitude, subjective norms intention, perceived behavioral control , Self-monitoring, action planning and coping planning)	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.	changes from baseline , 1 month and 6 Months follow-up
Secondary	Adolescent Sleep Hygiene Scale		changes from baseline , 1 month and 6 Months follow-up
Secondary	General Health Questionnaire	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)	changes from baseline , 1 month and 6 Months follow-up
Secondary	Pediatric Daytime Sleepiness Scale		changes from baseline , 1 month and 6 Months follow-up
Secondary	Sleep Disturbances Scale for Children		changes from baseline , 1 month and 6 Months follow-up
Secondary	Changes in health-related quality of life	health-related quality of life will be measured using the Pediatric Quality of Life Inventory™ Short Form 15 Generic Core Scales.	changes from baseline , 1 month and 6 Months follow-up
Secondary	Sleep knowledge questionnaire		changes from baseline , 1 month and 6 Months follow-up