Student Stress Levels and Management Through Meditation

February 7, 2019 updated by: California State University, Northridge

Physical Therapist Doctoral Student Stress Levels and Management Through Meditation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Northridge, California, United States, 91330-8411
        • California State University, Northridge

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Control group participants will continue their normal activities and not add any form of meditation during the study period.
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.
Behavioral: Meditation Group
twice daily 20 minute mantra-based meditation practice for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
8 weeks
Change in Perceived Stress Survey Questionnaire
Time Frame: At baseline and at 8 weeks post intervention
10-Item standardized survey tool for perceived stress level
At baseline and at 8 weeks post intervention
Change in Sleep Hygiene utilizing PSQI survey
Time Frame: survey at baseline, 1 month and at conclusion of 8 weeks
PSQI sleep survey administered 3 times during the study (baseline, 4 weeks and 8 weeks)
survey at baseline, 1 month and at conclusion of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California State University, Northridge

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beth J Phillips, PT, DPA, Full Professor

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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