Sleep QualitySleepQualityNCT03813420
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
A study testing Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQ) and The Short Form 36 Health Survey (SF-36) in people with Sleep Quality and Quality of Life, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
There is a high prevalence of poor sleep quality among university students studying in different areas such as medicine, nursing, art, science, social work etc. and in different countries. However, the studies done especially for physiotherapy students, and in Turkey, as well, are not many. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Quality of Life, Physical Activity
- What is being tested?
- Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQ) and The Short Form 36 Health Survey (SF-36)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2018to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being physiotherapy and rehabilitation students
- Being the age between 18-26 years old
- Being voluntary to participate to the study
Who cannot join
- Not having any systemic disease
- Any expressed psychological condition
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istinye University
Istanbul, 34010
About this study
Official title: Sleep Quality Among Physiotherapy Students and Its Relation to Quality of Life and Physical Activity Level
There is a high prevalence of poor sleep quality among university students studying in different areas such as medicine, nursing, art, science, social work etc. and in different countries. However, the studies done especially for physiotherapy students, and in Turkey, as well, are not many. Therefore, we aimed to search the sleep quality among physiotherapy students, and observe the association between the health related quality of life and physical activity level of the physiotherapy students.
The physiotherapy students were included. Their quality of sleep will be assessed by Pittsburgh Sleep Quality Index. The physical activity will be searched by International Physical Activity Questionnaire, and SF-36 will be used to assess quality of life. Data is going to analyzed statistically
Read the detailed description
Therefore, recent studies are focusing on the sleep quality of university students in different countries, and reporting that medical students pharmacy students, nursing students are experiencing poor quality of sleep. However, to our knowledge, studies done on sleep quality of students and especially the physiotherapy students are not available in Turkey, yet.
Hence, since the university students are one of the high risk groups for developing poor sleep quality, we aimed to evaluate if the sleep quality of the physiotherapy students in both gender are associated with their quality of life and physical activity level.
- Conditions
- Sleep Quality, Quality of Life, Physical Activity
- Being tested
- Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQ), The Short Form 36 Health Survey (SF-36)
- Keywords
- Sleep quality, Body mass index, Active life, Academic performance
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pittsburgh Sleep Quality Index (PSQI)Behavioural
Also called IPAQ, SF-36 Quality of life
The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month. It has seven components as subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.
Each component is scored from 0 to 3, and the Global Pittsburgh Quality of Sleep (PQS) score is the sum of the scores of the seven components that is between 0 and 21. The higher Global PQS scores indicate poor sleep quality and the cut off score for poor sleep is 5 and over.
International Physical Activity Questionnaire (IPAQ)Behavioural
Also called Pittsburgh Sleep Quality Index, SF-36
The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as low, moderate and vigorous physical activity that they engaged in during the last seven days prior to survey. Vigorous physical activity, defined by the questionnaire, referred to intense exercise that resulted in very rapid breathing and an elevated heart rate (e.g. intense weight lifting, aerobics, running, and cycling). Moderate physical activity was defined as less intense exercise that slightly heightened breathing and heart rate (e.g. less exertive cycling, fast walking, and light weight lifting).
The Short Form 36 Health Survey (SF-36)Behavioural
Also called IPAQ, Pittsburgh Sleep Quality Index
The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Additionally, the psychometric evaluation of the SF-36 generated two summary scores as the Mental Health Component Score and the Physical Health Component Score that the higher scores indicate better HRQOL.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy students | Other | 1. Pittsburgh Sleep Quality Index-PSQI:The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month
2. International Physical Activity Questionnaire-IPAQ: The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as the intensity of physical activity in the last seven days.
3. Short Form-36-SF-36: The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts. Receives: Behavioral: Pittsburgh Sleep Quality Index (PSQI); Behavioral: International Physical Activity Questionnaire (IPAQ); Behavioral: The Short Form 36 Health Survey (SF-36) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
The sleep quality of the students will be evaluated by means of the Turkish version of the Pittsburgh Sleep Quality Index through face-to-face interview. This assessment will provide us information about the type and duration of their sleep as well as their sleep efficiency, if there are any sleep disturbances or if they are using any sleep medications or not. Additionally, this will provide us about if the sleep quality affects their daytime functions.
Measured: 3 months
Secondary outcomes (1)
Physical activity
The physical activity of the participants will assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form. The frequency (days per week) and duration (hours) of walking, the intensity of their physical activity as if they are low, moderately and vigorously physical active or not will be searched. This covers the duration of the last seven days prior to survey.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start3 Sep 2018
- Primary completion1 Jul 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habibe Serap Inal, Istinye University
- Investigators
- Ekin Aktay Karlik, MSc, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813420
- Sponsor's protocol ID
- ISU
- Acronym
- SleepQuality
- Status last verified
- May 2022
- First submitted
- 31 Dec 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manzar MD, Zannat W, Hussain ME, Pandi-Perumal SR, Bahammam AS, Barakat D, Ojike NI, Olaish A, Spence DW. Dimensionality of the Pittsburgh Sleep Quality Index in the collegiate young adults. Springerplus. 2016 Sep 13;5(1):1550. doi: 10.1186/s40064-016-3234-x. eCollection 2016.
PubMed 27652123Almojali AI, Almalki SA, Alothman AS, Masuadi EM, Alaqeel MK. The prevalence and association of stress with sleep quality among medical students. J Epidemiol Glob Health. 2017 Sep;7(3):169-174. doi: 10.1016/j.jegh.2017.04.005. Epub 2017 May 5.
PubMed 28756825Chang SP, Shih KS, Chi CP, Chang CM, Hwang KL, Chen YH. Association Between Exercise Participation and Quality of Sleep and Life Among University Students in Taiwan. Asia Pac J Public Health. 2016 May;28(4):356-67. doi: 10.1177/1010539516645160. Epub 2016 Apr 28.
PubMed 27130632Elagra MI, Rayyan MR, Alnemer OA, Alshehri MS, Alsaffar NS, Al-Habib RS, Almosajen ZA. Sleep quality among dental students and its association with academic performance. J Int Soc Prev Community Dent. 2016 Jul-Aug;6(4):296-301. doi: 10.4103/2231-0762.186788.
PubMed 27583216
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality Among Physiotherapy Students and Its Relation to Quality of Life and Physical Activity Level
- ClinicalTrials.gov ID
- NCT03813420
- Acronym / sponsor ID
- SleepQuality / ISU
- Conditions
- Sleep Quality, Quality of Life, Physical Activity
- Keywords
- Sleep quality, Body mass index, Active life, Academic performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a high prevalence of poor sleep quality among university students studying in different areas such as medicine, nursing, art, science, social work etc. and in different countries. However, the studies done especially for physiotherapy students, and in Turkey, as well, are not many. Therefore, we aimed to search the sleep quality among physiotherapy students, and observe the association between the health related quality of life and physical activity level of the physiotherapy students.
The physiotherapy students were included. Their quality of sleep will be assessed by Pittsburgh Sleep Quality Index. The physical activity will be searched by International Physical Activity Questionnaire, and SF-36 will be used to assess quality of life. Data is going to analyzed statistically
Detailed description
Therefore, recent studies are focusing on the sleep quality of university students in different countries, and reporting that medical students pharmacy students, nursing students are experiencing poor quality of sleep. However, to our knowledge, studies done on sleep quality of students and especially the physiotherapy students are not available in Turkey, yet.
Hence, since the university students are one of the high risk groups for developing poor sleep quality, we aimed to evaluate if the sleep quality of the physiotherapy students in both gender are associated with their quality of life and physical activity level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy students | Other | Behavioral: Pittsburgh Sleep Quality Index (PSQI), Behavioral: International Physical Activity Questionnaire (IPAQ), Behavioral: The Short Form 36 Health Survey (SF-36)1. Pittsburgh Sleep Quality Index-PSQI:The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month 2. International Physical Activity Questionnaire-IPAQ: The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as the intensity of physical activity in the last seven days. 3. Short Form-36-SF-36: The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being physiotherapy and rehabilitation students
- Being the age between 18-26 years old
- Being voluntary to participate to the study
Key exclusion criteria (2 listed)
- Not having any systemic disease
- Any expressed psychological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI)Also: IPAQ, SF-36 Quality of lifeThe sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month. It has seven components as subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component is scored from 0 to 3, and the Global Pittsburgh Quality of Sleep (PQS) score is the sum of the scores of the seven components that is between 0 and 21. The higher Global PQS scores indicate poor sleep quality and the cut off score for poor sleep is 5 and over. | Behavioural | Physiotherapy students |
| International Physical Activity Questionnaire (IPAQ)Also: Pittsburgh Sleep Quality Index, SF-36The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as low, moderate and vigorous physical activity that they engaged in during the last seven days prior to survey. Vigorous physical activity, defined by the questionnaire, referred to intense exercise that resulted in very rapid breathing and an elevated heart rate (e.g. intense weight lifting, aerobics, running, and cycling). Moderate physical activity was defined as less intense exercise that slightly heightened breathing and heart rate (e.g. less exertive cycling, fast walking, and light weight lifting). | Behavioural | Physiotherapy students |
| The Short Form 36 Health Survey (SF-36)Also: IPAQ, Pittsburgh Sleep Quality IndexThe Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Additionally, the psychometric evaluation of the SF-36 generated two summary scores as the Mental Health Component Score and the Physical Health Component Score that the higher scores indicate better HRQOL. | Behavioural | Physiotherapy students |
Primary outcome
Sleep Quality
Time frame: 3 months
The sleep quality of the students will be evaluated by means of the Turkish version of the Pittsburgh Sleep Quality Index through face-to-face interview. This assessment will provide us information about the type and duration of their sleep as well as their sleep efficiency, if there are any sleep disturbances or if they are using any sleep medications or not. Additionally, this will provide us about if the sleep quality affects their daytime functions.
1 secondary outcome
Physical activity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 27652123Manzar MD, Zannat W, Hussain ME, Pandi-Perumal SR, Bahammam AS, Barakat D, Ojike NI, Olaish A, Spence DW. Dimensionality of the Pittsburgh Sleep Quality Index in the collegiate young adults. Springerplus. 2016 Sep 13;5(1):1550. doi: 10.1186/s40064-016-3234-x. eCollection 2016.
- Results publication: PubMed 28756825Almojali AI, Almalki SA, Alothman AS, Masuadi EM, Alaqeel MK. The prevalence and association of stress with sleep quality among medical students. J Epidemiol Glob Health. 2017 Sep;7(3):169-174. doi: 10.1016/j.jegh.2017.04.005. Epub 2017 May 5.
- Results publication: PubMed 27130632Chang SP, Shih KS, Chi CP, Chang CM, Hwang KL, Chen YH. Association Between Exercise Participation and Quality of Sleep and Life Among University Students in Taiwan. Asia Pac J Public Health. 2016 May;28(4):356-67. doi: 10.1177/1010539516645160. Epub 2016 Apr 28.
- Results publication: PubMed 27583216Elagra MI, Rayyan MR, Alnemer OA, Alshehri MS, Alsaffar NS, Al-Habib RS, Almosajen ZA. Sleep quality among dental students and its association with academic performance. J Int Soc Prev Community Dent. 2016 Jul-Aug;6(4):296-301. doi: 10.4103/2231-0762.186788.
- Individual participant dataSharing planned: No
Related trials for Sleep Quality
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekin Aktay Karlik, MSc study chair
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQ) and The Short Form 36 Health Survey (SF-36) in people with Sleep Quality and Quality of Life, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03813420, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.