Insomnia, Physical Activity Level and Stress Level

Sleep Initiation and Maintenance Disorders Clinical Trial

— PA  

Official title:

Examination of Insomnia, Physical Activity Level and Stress Level in University Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06306495
• Other study ID #: 26.01.2022/17
• Status: Completed
• Start date: March 27, 2022
• Est. completion date: January 29, 2024

Study information

• Verified date: March 2024
• Source: Halic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: January 29, 2024
• Est. primary completion date: August 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• International Physical Activity Survey
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.

Locations

Country	Name	City	State
Turkey	Halic University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

Sutton EL. Insomnia. Ann Intern Med. 2021 Mar;174(3):ITC33-ITC48. doi: 10.7326/AITC202103160. Epub 2021 Mar 9. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of insomnia in university students	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"	17 months
Secondary	The effect of insomnia on physical activity level	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
Secondary	The effect of insomnia on stress levels in university students	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	17 months
Secondary	Effects of sleep hygiene on insomnia in university students	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	17 months