SleepNCT05253092
The Effects of Mindfulness Meditation on Sleep Quality and Perceived Stress
A study testing Virtual mindfulness meditation in people with Sleep, run by University of the Sciences in Philadelphia at 1 site in United States.
Trial summary
Higher education students 18 years or older will participate in 8- virtual mindfulness meditation sessions over 3 to 4 weeks (minimum of 3 sessions per week). Each session will be 30 minutes long, 15 minutes for guided mindfulness meditation run by researchers, followed by a short discussion period to understand… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Virtual mindfulness meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2022to 31 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a student at the University of the Sciences
- 18 years or older and fluent in English
- Students must have access to a device with internet connection and Zoom capabilities
- Students must have a smartphone to download the Fitbit®: Health \& Wellness application.
Who cannot join
- Students who do not attend the University of the Sciences
- Students do not have access to an internet connection and an electronic device
- Students do not comprehend and speak English
- Students under the age of 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of the Sciences
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effect of Mindfulness Meditation on Sleep Quality and Perceived Stress of Students in Higher Education
Higher education students 18 years or older will participate in 8- virtual mindfulness meditation sessions over 3 to 4 weeks (minimum of 3 sessions per week). Each session will be 30 minutes long, 15 minutes for guided mindfulness meditation run by researchers, followed by a short discussion period to understand mindfulness meditation better. Before starting the mindfulness meditation session, baseline data will be collected.
Read the detailed description
Sleep consider a restorative occupation that affects other daily activities, such as academic performance. Mindfulness meditation may improve sleep quality and decrease perceived stress in higher education students. There is limited research on virtual mindfulness meditation involving sleep quality and perceived stress in higher education students. The researchers will measure changes in sleep quality and perceived stress after participants completed 8- virtual mindfulness meditation sessions using PSQI, PSS, and the Fitbit Inspire 2™.
- Conditions
- Sleep
- Being tested
- Virtual mindfulness meditation
- Keywords
- Sleep, perceived stress, higher education, mindfulness meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual mindfulness meditationOther
Subjects will participate in 30 minutes of a virtual mindfulness meditation session, totaling eight sessions.
| Study group | Role | What they receive |
|---|---|---|
| Virtual mindfulness meditation | Other | Not described Receives: Other: Virtual mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a nine-question, self-report index that assesses quality of sleep. The questionnaire is made up of scaled responses from 0-3; 0 is not during the past month, 1 is less than once a week, 2 is once or twice a week, and 3 is three or more times a week. If the individual scores higher than a 5 overall, it is an indication of poor sleep quality.
Measured: 10 minutes
Secondary outcomes (1)
Perceived Stress Scale (PSS)
The PSS is a self-report, ten question scale that measures perceived stress. This assessment uses a five-point Likert type scale to record responses. Responses range from 0, indicating "never" to 4, indicating "very often". A higher total score indicates higher perceived stress. Questions are general and ask about stressors in the last month.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start17 Jan 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Sciences in Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabila Enam, University of the Sciences in Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253092
- Sponsor's protocol ID
- 1519081-3
- Status last verified
- Aug 2022
- First submitted
- 1 Feb 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Meditation on Sleep Quality and Perceived Stress of Students in Higher Education
- ClinicalTrials.gov ID
- NCT05253092
- Acronym / sponsor ID
- 1519081-3
- Conditions
- Sleep
- Keywords
- Sleep, perceived stress, higher education, mindfulness meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of the Sciences in PhiladelphiaUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 23 Feb 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.
Higher education students 18 years or older will participate in 8- virtual mindfulness meditation sessions over 3 to 4 weeks (minimum of 3 sessions per week). Each session will be 30 minutes long, 15 minutes for guided mindfulness meditation run by researchers, followed by a short discussion period to understand mindfulness meditation better. Before starting the mindfulness meditation session, baseline data will be collected.
Detailed description
Sleep consider a restorative occupation that affects other daily activities, such as academic performance. Mindfulness meditation may improve sleep quality and decrease perceived stress in higher education students. There is limited research on virtual mindfulness meditation involving sleep quality and perceived stress in higher education students. The researchers will measure changes in sleep quality and perceived stress after participants completed 8- virtual mindfulness meditation sessions using PSQI, PSS, and the Fitbit Inspire 2™.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual mindfulness meditation | Other | Other: Virtual mindfulness meditation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be a student at the University of the Sciences
- 18 years or older and fluent in English
- Students must have access to a device with internet connection and Zoom capabilities
- Students must have a smartphone to download the Fitbit®: Health \& Wellness application.
Key exclusion criteria (4 listed)
- Students who do not attend the University of the Sciences
- Students do not have access to an internet connection and an electronic device
- Students do not comprehend and speak English
- Students under the age of 18 years old
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 |
|---|---|---|
| Virtual mindfulness meditationSubjects will participate in 30 minutes of a virtual mindfulness meditation session, totaling eight sessions. | Other | Virtual mindfulness meditation |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 10 minutes
The PSQI is a nine-question, self-report index that assesses quality of sleep. The questionnaire is made up of scaled responses from 0-3; 0 is not during the past month, 1 is less than once a week, 2 is once or twice a week, and 3 is three or more times a week. If the individual scores higher than a 5 overall, it is an indication of poor sleep quality.
1 secondary outcome
Perceived Stress Scale (PSS)
Time frame: 10 minutes
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 29 Aug 2022.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual mindfulness meditation in people with Sleep, run by University of the Sciences in Philadelphia at 1 site in United States.
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 4 inclusion and 4 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 29 Aug 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 United States. 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?
Pittsburgh Sleep Quality Index (PSQI) (time frame: 10 minutes). 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 29 Aug 2022.