The Effects of Mindfulness Meditation on Sleep Quality and Perceived Stress

• Sponsor: University of the Sciences in Philadelphia (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05253092
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Other: Virtual mindfulness meditation	N/A

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

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Mindfulness Meditation on Sleep Quality and Perceived Stress of Students in Higher Education
• Actual Study Start Date: Jan 17, 2022
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: May 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pittsburgh Sleep Quality Index (PSQI) [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.

Secondary Outcome Measures

1. Perceived Stress Scale (PSS) [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.

Other Outcome Measures

1. Fitbit Inspire 2 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of the Sciences	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of the Sciences in Philadelphia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nabila Enam, Assistant Professor, University of the Sciences in Philadelphia
• ClinicalTrials.gov Identifier: NCT05253092
• Other Study ID Numbers: 1519081-3
• First Posted: Feb 23, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nabila Enam, Assistant Professor, University of the Sciences in Philadelphia: Sleep, perceived stress, higher education, mindfulness meditation

Study Results

No Results Posted as of Aug 2, 2022