Sleep QualityNCT05296616
Sleep Quality, Stress Level and Heart Rate Variability of University Students
A study testing Mindfulness Based Stress Reduction Intervention in people with Sleep Quality and Stress Level, run by İstanbul Yeni Yüzyıl Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on sleep quality, stress level and heart rate variability of university students Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test. Read more about this study
- Who is it for?
- Ages 17 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Stress Level, Heart Rate Variability
- What is being tested?
- Mindfulness Based Stress Reduction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2022to 18 Jan 2023
- 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 17 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being a student of the relevant faculty,
- No barriers to accessing technology for participation in the online program,
- No visual or hearing impairment
Who cannot join
- Not being a student of the relevant faculty,
- Having barriers to accessing technology for participation in the online program,
- Having visual or hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-Based Stress Reduction Intervention on Sleep Quality, Stress Level and Heart Rate Variability of University Students
Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on sleep quality, stress level and heart rate variability of university students Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.
Hypotheses:
Read more
H1: The sleep quality level scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the students in the control group. H2: Students in the intervention group participating in the mindfulness-based stress reduction initiative will decrease their stress level level scores compared to the students in the control group. H3: The heart rate variability of the students in the intervention group participating in the mindfulness-based stress reduction initiative will be higher than the students in the control group.
H4: The sleep quality level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores. H5: The stress level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores. H6: The heart rate variability level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.
- Conditions
- Sleep Quality, Stress Level, Heart Rate Variability
- Being tested
- Mindfulness Based Stress Reduction Intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction InterventionBehavioural
Mindfulness Based Stress Reduction intervention is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 90 minute sessions, once per week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| MSQSLHRV | Experimental | The group in which the mindfulness-based stress reduction intervention will be implemented. Receives: Behavioral: Mindfulness Based Stress Reduction Intervention |
| Control | No intervention | The group to which mindfulness-based stress reduction intervention will not be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality Level
The Pittsburgh Sleep Quality Index: The 18 items scored are divided into 7 component scores. Some ingredients consist of a single substance, while others are obtained by combining several substances. Each item is assessed on a scale between 0-3. These components are; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction. The sum of these seven component scores gives the overall index score. Your total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence or prevalence of sleep disorders.
Measured: for 8 months
Secondary outcomes (2)
Stress Level
Perceived Stress Scale is a scale consisting of 14 questions. Participants in the study evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)." The Perceived Stress Scale includes 7 (items 4.5.6.7.9.10. and 13.) reverse scored statements. Total scale scores range from 0 to 56. An increase in the total score indicates an increase in the perceived stress level of the individual.
Measured: for 8 months
Heart Rate Variability
CorSense HRV monitors were purchased from the Elite HRV company for use in the study. Readings will be collected through the Elite HRV app designed for mobile devices.
RMSSD and LF/HF data will be received for each reading from the application. According to the Elite HRV website, the platform includes RMSSD calculations for the R-R range recorded by industry standards and defines 0.04-0.15 Hz waves as LF and 0.15-0.40 Hz waves as HF.
Measured: for 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start18 May 2022 (estimated)
- Primary completion18 Nov 2022 (estimated)
- Study completion18 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İstanbul Yeni Yüzyıl Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve BAT TONKUŞ, İstanbul Yeni Yüzyıl Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296616
- Sponsor's protocol ID
- 2022/03-835
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Stress Reduction Intervention on Sleep Quality, Stress Level and Heart Rate Variability of University Students
- ClinicalTrials.gov ID
- NCT05296616
- Acronym / sponsor ID
- 2022/03-835
- Conditions
- Sleep Quality, Stress Level, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- İstanbul Yeni Yüzyıl ÜniversitesiUniversity, hospital or other
- Study start
- 18 May 2022 (estimated)
- Primary completion
- 18 Nov 2022 (estimated)
- Study completion
- 18 Jan 2023 (estimated)
- First posted
- 25 Mar 2022 (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.
Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on sleep quality, stress level and heart rate variability of university students Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.
Hypotheses:
H1: The sleep quality level scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the students in the control group. H2: Students in the intervention group participating in the mindfulness-based stress reduction initiative will decrease their stress level level scores compared to the students in the control group. H3: The heart rate variability of the students in the intervention group participating in the mindfulness-based stress reduction initiative will be higher than the students in the control group.
H4: The sleep quality level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores. H5: The stress level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores. H6: The heart rate variability level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSQSLHRV | Experimental | Behavioral: Mindfulness Based Stress Reduction InterventionThe group in which the mindfulness-based stress reduction intervention will be implemented. |
| Control | No intervention | –The group to which mindfulness-based stress reduction intervention will not be applied |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Being a student of the relevant faculty,
- No barriers to accessing technology for participation in the online program,
- No visual or hearing impairment
Key exclusion criteria (3 listed)
- Not being a student of the relevant faculty,
- Having barriers to accessing technology for participation in the online program,
- Having visual or hearing impairment
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 |
|---|---|---|
| Mindfulness Based Stress Reduction InterventionMindfulness Based Stress Reduction intervention is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 90 minute sessions, once per week for eight weeks. | Behavioural | MSQSLHRV |
Primary outcome
Sleep Quality Level
Time frame: for 8 months
The Pittsburgh Sleep Quality Index: The 18 items scored are divided into 7 component scores. Some ingredients consist of a single substance, while others are obtained by combining several substances. Each item is assessed on a scale between 0-3. These components are; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction. The sum of these seven component scores gives the overall index score. Your total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence or prevalence of sleep disorders.
2 secondary outcomes
Stress Level
Time frame: for 8 months
Heart Rate Variability
Time frame: for 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction Intervention in people with Sleep Quality and Stress Level, run by İstanbul Yeni Yüzyıl Üniversitesi 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 3 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: status not confirmed, as of the sponsor's last update on 8 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Bat Tonkus, PhD Cand (05055951889, mervebat.tonkus@yeniyuzyil.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality Level (time frame: for 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2022.