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Student Stress Levels and Management Through Meditation

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation Group
Sponsored by
California State University, Northridge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Student Stress, Meditation, Sleep Quality, Blood Pressure

Eligibility Criteria

22 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • California State University, Northridge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Meditation Group

Control Group

Arm Description

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.

Control group participants will continue their normal activities and not add any form of meditation during the study period.

Outcomes

Primary Outcome Measures

Change in Blood Pressure
Omron HEM 907XL professional automatic blood pressure monitor used at baseline and at 8 weeks post intervention
Change in Perceived Stress Survey Questionnaire
10-Item standardized survey tool for perceived stress level
Change in Sleep Hygiene utilizing PSQI survey
PSQI sleep survey administered 3 times during the study (baseline, 4 weeks and 8 weeks)

Secondary Outcome Measures

Full Information

First Posted
April 18, 2016
Last Updated
February 7, 2019
Sponsor
California State University, Northridge
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1. Study Identification

Unique Protocol Identification Number
NCT02821611
Brief Title
Student Stress Levels and Management Through Meditation
Official Title
Physical Therapist Doctoral Student Stress Levels and Management Through Meditation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
California State University, Northridge

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The professional program in Physical Therapy is rigorous and demanding on students, resulting in high levels of fatigue, stress, and sleep disturbance that can impact student performance and wellbeing. This project seeks to investigate ways to reduce student stress, monitor their quality of sleep and possibly enhance their learning through the practice of meditation.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Student Stress, Meditation, Sleep Quality, Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group participants will continue their normal activities and not add any form of meditation during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Meditation Group
Intervention Description
twice daily 20 minute mantra-based meditation practice for 8 weeks
Primary Outcome Measure Information:
Title
Change in Blood Pressure
Description
Omron HEM 907XL professional automatic blood pressure monitor used at baseline and at 8 weeks post intervention
Time Frame
8 weeks
Title
Change in Perceived Stress Survey Questionnaire
Description
10-Item standardized survey tool for perceived stress level
Time Frame
At baseline and at 8 weeks post intervention
Title
Change in Sleep Hygiene utilizing PSQI survey
Description
PSQI sleep survey administered 3 times during the study (baseline, 4 weeks and 8 weeks)
Time Frame
survey at baseline, 1 month and at conclusion of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth J Phillips, PT, DPA
Organizational Affiliation
Full Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
California State University, Northridge
City
Northridge
State/Province
California
ZIP/Postal Code
91330-8411
Country
United States

12. IPD Sharing Statement

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Student Stress Levels and Management Through Meditation

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