- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05253092
The Effects of Mindfulness Meditation on Sleep Quality and Perceived Stress
August 26, 2022 updated by: Nabila Enam, University of the Sciences in Philadelphia
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of the Sciences
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Virtual mindfulness meditation
|
Subjects will participate in 30 minutes of a virtual mindfulness meditation session, totaling eight sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale (PSS)
Time Frame: 10 minutes
|
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.
|
10 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fitbit Inspire 2
Time Frame: up to 5 weeks or until study completion
|
Fitbit device track sleep within participants natural environment.
The Fitbit Inspire 2 collects data on all stages of sleep throughout night, which helps to calculate sleep efficiency.
|
up to 5 weeks or until study completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 17, 2022
Primary Completion (Actual)
July 31, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
February 1, 2022
First Submitted That Met QC Criteria
February 11, 2022
First Posted (Actual)
February 23, 2022
Study Record Updates
Last Update Posted (Actual)
August 29, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1519081-3
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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