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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 February 2019 |
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Main ID: |
ISRCTN13083118 |
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Date of registration:
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10/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Sleep Promotion Program on Sleep behavioral Practices among Adolescents in Selected Schools
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Scientific title:
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Efficacy of Sleep Promotion Program on Sleep Hygiene Practices, Sleep Quality and Daytime Functioning among Adolescents in Selected Schools: A Randomized Controlled Trial |
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Date of first enrolment:
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11/07/2013 |
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Target sample size:
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660 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN13083118 |
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Study type:
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Interventional |
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Study design:
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Multi-centre randomized controlled trial (Quality of life)
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Bindu
John |
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Address:
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College of Health Sciences
Nursing Department
University of Bahrain
32038
Sakeer
Bahrain |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sleep disturbances
Mental and Behavioural Disorders
Sleep disturbances
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Intervention(s)
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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).
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Primary Outcome(s)
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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)
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Secondary Outcome(s)
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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
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Secondary ID(s)
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NU/CEC/Ph.D-44/2011
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Source(s) of Monetary Support
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Nitte University
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Ethics review
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Status:
Approval date:
Contact:
Central Ethical Committee (Nitte University), 16/04/2012, ref: NU/CEC/Ph.D-44/2011
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2014 |
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URL:
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