- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821611
Student Stress Levels and Management Through Meditation
Physical Therapist Doctoral Student Stress Levels and Management Through Meditation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Utilizing a randomized controlled study design, a cohort of doctoral students in their first year of physical therapist education will undergo an 8 week intervention of a mantra-based Meditation (twice daily 20 minutes) with pre and post measures of blood pressure, sleep hygiene via the Pittsburgh Sleep Quality Index (PSQI) and stress surveys, including Perceived Stress Scale (PSS) and Visual Analogue Scale for stress (VAS), as well as daily logs of sleep to assess sleep quality.
As many as 32 students (total number in cohort) per year may participate with 1/2 serving as controls and 1/2 undergoing the meditation practice for 8 weeks.
Baseline measurement details:
QUESTIONNAIRES: Each participant will be given a 1-item Visual Analogue Scale for stress (VAS), a 10 item Perceived Stress Scale (PSS), and a 9 item Pittsburgh Sleep Quality Index (PSQI) questionnaire. The VAS simply asks subjects to score how much stress they are feeling at that one moment in time on a 0-100 scale. The PSQI scores and assesses sleep quality and disturbances over a 1-month time interval and will be administered at the 4 week mark 1/2 way into the study as well as at pre and post intervention data collection events.
BLOOD PRESSURE: Blood pressure will be measured individually in a separate room to ensure confidentiality. The BP measurements will be administered using an Omron professional automatic blood pressure monitor (model number HEM 907X) to ensure comfort/safety and the accuracy of the reading. Also for accuracy of blood pressure measurements subjects will be asked to refrain from caffeine (coffee, tea or chocolate), cigarettes/nicotine, or exercise that morning until after measurements are taken and avoid alcohol the evening prior. One identified researcher will take all blood pressure reading and will be blinded to which subjects are part of the research or the control groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Northridge, California, United States, 91330-8411
- California State University, Northridge
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Graduate student in the first year of the Doctorate of Physical Therapy (DPT) program at California State University, Northridge (CSUN)
Exclusion Criteria:
- Taking blood pressure or sleep medication; or already currently practicing a daily meditation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Control group participants will continue their normal activities and not add any form of meditation during the study period.
|
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Experimental: Meditation Group
Participants in the experimental group are practicing a mantra-based meditation twice daily for 20 minutes over the 8 week intervention period to reduce stress and blood pressure and enhance quality of sleep.
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twice daily 20 minute mantra-based meditation practice for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Blood Pressure
Time Frame: 8 weeks
|
Omron HEM 907XL professional automatic blood pressure monitor used at baseline and at 8 weeks post intervention
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8 weeks
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Change in Perceived Stress Survey Questionnaire
Time Frame: At baseline and at 8 weeks post intervention
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10-Item standardized survey tool for perceived stress level
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At baseline and at 8 weeks post intervention
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Change in Sleep Hygiene utilizing PSQI survey
Time Frame: survey at baseline, 1 month and at conclusion of 8 weeks
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PSQI sleep survey administered 3 times during the study (baseline, 4 weeks and 8 weeks)
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survey at baseline, 1 month and at conclusion of 8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Beth J Phillips, PT, DPA, Full Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1314-136-b
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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