- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06306495
Insomnia, Physical Activity Level and Stress Level (PA)
March 5, 2024 updated by: Seda Saka, Halic University
Examination of Insomnia, Physical Activity Level and Stress Level in University Students
Insomnia is a common, acute, intermittent, or chronic complaint of unwanted sleep difficulties characterized by sleep disturbance.
Important risk factors leading to insomnia: advanced age, poor health, work stress, shift work, loss of a loved one, divorce, domestic violence, excessive anxiety, repressed personality, perfectionism, neuroticism, alcohol and substance abuse, excessive caffeine intake, excessive smoking, low socio-economic status and low physical activity level.
Research shows that college students face more sleep problems than the general public.
Factors that disrupt the sleep hygiene of university students; Students' excessive use of computers during lecture and exam periods, exposure to lights and screens for long periods of time, and environmental changes.
The aim of this study is to determine the prevalence of insomnia in healthy individuals after the start of face-to-face education in university students after the pandemic period and to determine the physical activity associated with insomnia in this population group.
Examining levels and other behavioral factors.
The research was conducted on students studying at Istanbul Rumeli University, Haliç University and Yalova University between March 2022 and August 2022.
It will be held online via Google Forms with students between the ages of 18-25.
Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, and Pittsburgh Sleep Quality Index.
An application will be made to obtain approval from the Haliç University Non-Interventional Clinical Research Ethics Committee.
Informed consent will be obtained from people participating in the research.
Statistical analysis of the data will be done with IBM SPSS 23.0 software.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
473
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Halic University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The population of the study is university education in the Marmara Region.
consists of continuing students.
The study sample consists of associate and undergraduate students studying in the field of Health Sciences, between the ages of 18-25, who continue their university education in Istanbul and Yalova.
Description
Inclusion Criteria:
- Between the ages of 18-25,
- Associate and undergraduate students studying in the field of health sciences
- Agreeing to participate in the study,
- Native speaker of Turkish,
- Male and female individuals
Exclusion Criteria:
- Refusing to participate in the study,
- Having a diagnosed psychiatric illness,
- Using any medical medication that affects sleep
- Having a health condition that prevents physical activity,
- Be missing data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
University students
Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale and Pittsburgh Sleep Quality Index administered to all participants.
|
Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale and Pittsburgh Sleep Quality Index administered to all participants.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of insomnia in university students
Time Frame: 17 months
|
It will be evaluated with the Pittsburgh Sleep Quality Index.
Pittsburgh Sleep Quality Index (PSQI) is a scale that assesses sleep quality and disturbance over the past month.
It consists of 24 questions, 19 of which are self-report and 5 of which are answered by a spouse or roommate.
The self-report section consisting of 19 questions was used in this study.
The 18 scored questions of the scale consist of 7 components (Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleep Medication Use and Daytime Dysfunction).
Each component is evaluated on a 0-3 point scale and the total score of the 7 components gives the total score of the scale.
The total score varies between 0 and 21.
A total score greater than 5 means "poor sleep quality"
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17 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of insomnia on physical activity level
Time Frame: 17 months
|
It will be evaluated with the International Physical Activity Questionnaire Short Form (IPAQ-SF).IPAQ-SF was used to determine physical activity levels.
This is a seven-question self-report questionnaire that assesses physical activity over the past 7 days.
According to IPAQ-SF records, there are four levels of intensity: sitting, walking, moderate intensity (e.g.
leisure cycling) and vigorous intensity (e.g.
jogging or aerobics)
|
17 months
|
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The effect of insomnia on stress levels in university students
Time Frame: 17 months
|
It will be evaluated with the Distress Tolerance Scale (DTS).DTS; This scale aims to determine the stress endurance of the patient based on individual variations.
DTS is a 15-item scale developed to measure individual differences in the capacity to withstand distress.
The scale consists of 3 sub-factors (self-efficacy, tolerance, regulation).
A high score on the scale indicates indicates a high level of resilience
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17 months
|
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Effects of sleep hygiene on insomnia in university students
Time Frame: 17 months
|
Evaluated by Sleep Hygiene Index (SHI).The SHI form consists of 13 questions and evaluates the sleep behaviors that constitute the sleep hygiene of the participants.
Scores ranged from 13 to 65, with higher scores indicating poorer sleep hygiene in the participants.
It has been reported that participants with high scores on the form have worse sleep hygiene
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17 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Özge Ökcü, phdc, Halic University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sutton EL. Insomnia. Ann Intern Med. 2021 Mar;174(3):ITC33-ITC48. doi: 10.7326/AITC202103160. Epub 2021 Mar 9.
- Amaral AP, Soares MJ, Pinto AM, Pereira AT, Madeira N, Bos SC, Marques M, Roque C, Macedo A. Sleep difficulties in college students: The role of stress, affect and cognitive processes. Psychiatry Res. 2018 Feb;260:331-337. doi: 10.1016/j.psychres.2017.11.072. Epub 2017 Dec 2.
- Williams AB, Dzierzewski JM, Griffin SC, Lind MJ, Dick D, Rybarczyk BD. Insomnia Disorder and Behaviorally Induced Insufficient Sleep Syndrome: Prevalence and Relationship to Depression in College Students. Behav Sleep Med. 2020 Mar-Apr;18(2):275-286. doi: 10.1080/15402002.2019.1578772. Epub 2019 Feb 21.
- Hartescu I, Morgan K. Regular physical activity and insomnia: An international perspective. J Sleep Res. 2019 Apr;28(2):e12745. doi: 10.1111/jsr.12745. Epub 2018 Aug 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2022
Primary Completion (Actual)
August 12, 2023
Study Completion (Actual)
January 29, 2024
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26.01.2022/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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