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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02821611
Other study ID # 1314-136-b
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date April 2016

Study information

Verified date February 2019
Source California State University, Northridge
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Meditation Group
twice daily 20 minute mantra-based meditation practice for 8 weeks

Locations

Country Name City State
United States California State University, Northridge Northridge California

Sponsors (1)

Lead Sponsor Collaborator
California State University, Northridge

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Blood Pressure Omron HEM 907XL professional automatic blood pressure monitor used at baseline and at 8 weeks post intervention 8 weeks
Primary Change in Perceived Stress Survey Questionnaire 10-Item standardized survey tool for perceived stress level At baseline and at 8 weeks post intervention
Primary 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
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