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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05253092
Other study ID # 1519081-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2022
Est. completion date July 31, 2022

Study information

Verified date August 2022
Source University of the Sciences in Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 mindfulness meditation better. Before starting the mindfulness meditation session, baseline data will be collected.


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™.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual mindfulness meditation
Subjects will participate in 30 minutes of a virtual mindfulness meditation session, totaling eight sessions.

Locations

Country Name City State
United States University of the Sciences Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of the Sciences in Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Fitbit Inspire 2 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
Primary 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. 10 minutes
Secondary 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. 10 minutes
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