Condition category
Mental and Behavioural Disorders
Date applied
04/09/2015
Date assigned
10/09/2015
Last edited
14/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sleep plays an important role in both physical and emotional wellbeing. Studies have shown that many adolescents do not get enough sleep at night, and as many as 25% report less than six hours of sleep each night. There is a lot of evidence to suggest that not getting enough sleep can have a negative influence on academic performance, as when we are asleep, information that is learned throughout the day is converted into long term memories (memory consolidation). Sleep has also been found to play a key role in lowering stress levels, and so not getting enough sleep can lead to mood disturbances such as anxiety or depression. It is recommended that adolescents need between eight and nine hours of sleep every night, in order to ensure that they are alert during the day. Treatment encouraging good sleep practices to counteract the adverse effects of lack of sleep is a relatively unexplored area of research. The aim of this study is to find out whether providing adolescents with an educational programme promoting good sleep hygiene would have a positive impact on their sleeping habits and alertness throughout the day.

Who can participate?
Adolescents studying in schools in Mangalore who can understand the English language.

What does the study involve?
Participants are randomly allocated into two groups. Those in the first group (intervention group) are provided with a sleep promotion programme. This involves educating participants about good sleep practices, teaching relaxation techniques and improving time management (planning and consciously controlling the time spent on different activities). Participants in the control group receive normal, routine education, with no additional training. Quality and length of sleep are assessed using questionnaires at the start of the study (baseline), after 10 days, and after 6 weeks.

What are the possible benefits and risks of participating?
Possible benefits of participating include improving sleeping habits and quality of sleep. There are no known risks of participating in the study.

Where is the study run from?
Nine schools in the Mangalore region of India.

When is the study starting and how long is it expected to run for?
July 2011 to August 2014

Who is funding the study?
Nitte University (India)

Who is the main contact?
Ms Bindu John

Trial website

Contact information

Type

Scientific

Primary contact

Ms Bindu John

ORCID ID

http://orcid.org/0000-0001-9749-0592

Contact details

College of Health Sciences
Nursing Department
University of Bahrain
Sakeer
32038
Bahrain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NU/CEC/Ph.D-44/2011

Study information

Scientific title

Efficacy of Sleep Promotion Program on Sleep Hygiene Practices, Sleep Quality and Daytime Functioning among Adolescents in Selected Schools: A Randomized Controlled Trial

Acronym

Study hypothesis

The study aims to look at the effect of sleep promotion program on adolescents' sleep hygiene practices, sleep quality, daytime sleepiness and at the moment functioning, compared with those adolescents' who are on a regular educational program in the schools.

Ethics approval

Central Ethical Committee (Nitte University), 16/04/2012, ref: NU/CEC/Ph.D-44/2011

Study design

Multi-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Condition

Sleep disturbances

Intervention

Participants are randomly allocated into the control group or the intervention group:

Intervention group: The treatment consisted of an educational intervention, which was provided in two sessions over a 30 minute and 20 min sessions; a visualization or imagery training which was provided over two sessions each with a duration of 25-30 minutes; and time management skills - which is combined along with second day of visualization training for 15 minutes. The whole intervention for the experimental group is completed over a 3 week period.

Control group: Provided with routine education with no additional training throughout the intervention period. Participants in the control group are offered the intervention after the end of the study (for ethical fairness).

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

All outcomes are measured at baseline, after 10 days, and after 6 weeks:
1. Improvement in Sleep Hygiene Practices, measured using the sleep Hygiene Index questionnaire
2. Sleep Quality measured using the Pittsburgh Sleep Quality Index questionnaire
3. Daytime Sleepiness measured using the Cleveland Adolescent Sleepiness Questionnaire
4. Emotional functioning measured using the PedsQL TM- Present Functioning Scales (Visual Analog Scale)

Secondary outcome measures

All outcomes are measured at baseline, after 10 days, and after 6 weeks:
1. Improvement in sleep duration measured using the questionnaire for collecting demographic data, with some additional questions regarding sleep (in hours and minutes). For example "How much sleep you get on a average during a school day?" and "How much sleep do you get on an average during a weekend?"
2. Improvement in self-reported sleep problems measured using the PSQI scale

Overall trial start date

01/07/2011

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adolescents studying in various schools in Mangalore, India,
2. Aged from 11 to 17 years (grade VI to grade XII)
3. Who can comprehend English Language.

Participant type

Healthy volunteer

Age group

Other

Gender

Both

Target number of participants

660

Participant exclusion criteria

1. Those who are diagnosed as having a sleep disorder or a psychiatric problem and who are on treatment 2. Those who are on medication for known allergies

Recruitment start date

11/07/2013

Recruitment end date

24/06/2014

Locations

Countries of recruitment

India

Trial participating centre

Kanachur Public School
Mangalore University Road Deralakatte
Mangalore
575 018
India

Trial participating centre

Narayana Guru College
Barke Road Kudroli
Mangalore
575 003
India

Trial participating centre

Lourdes Central School
Bejai Church Road
Mangalore
575 004
India

Trial participating centre

Canara High School
Kodailbail
Mangalore
575 003
India

Trial participating centre

St. Rita's English Higher Primary School
Ccb Point Attend Kankanady
Mangalore
575 002
India

Trial participating centre

Canara High School
Urwa Nehru Avenue
Mangalore
575 006
India

Trial participating centre

Canara Higher Primary School
Urwa
Mangalore
575 003
India

Trial participating centre

Cascia High School
Jeppu
Mangalore
575 001
India

Trial participating centre

Sarojini Madhusudhan Kushe College
P.V.S. Bhag, Attavar
Mangalore
575 001
India

Sponsor information

Organisation

Nitte University

Sponsor details

Medical Sciences Complex
Deralakatte
Mangalore
575018
India

Sponsor type

University/education

Website

www.nitte.edu.in

Funders

Funder type

University/education

Funder name

Nitte University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Part of the study to be published in 6 months, with the full study being published in 6-9 months.

Intention to publish date

30/04/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes