NCT02821611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

April 18, 2016

Last Update Submit

February 7, 2019

Conditions

Keywords

Student StressMeditationSleep QualityBlood Pressure

Outcome Measures

Primary Outcomes (3)

  • Change in Blood Pressure

    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

    10-Item standardized survey tool for perceived stress level

    At baseline and at 8 weeks post intervention

  • Change in Sleep Hygiene utilizing PSQI survey

    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

Study Arms (2)

Meditation Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

twice daily 20 minute mantra-based meditation practice for 8 weeks

Meditation Group

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Graduate student in the first year of the Doctorate of Physical Therapy (DPT) program at California State University, Northridge (CSUN)

You may not qualify if:

  • Taking blood pressure or sleep medication; or already currently practicing a daily meditation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California State University, Northridge

Northridge, California, 91330-8411, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Beth J Phillips, PT, DPA

    Full Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

July 1, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 11, 2019

Record last verified: 2019-02

Locations