Stress, PsychologicalNCT02821611
Student Stress Levels and Management Through Meditation
A study testing Meditation Group in people with Stress, Psychological, run by California State University, Northridge at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Meditation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Graduate student in the first year of the Doctorate of Physical Therapy (DPT) program at California State University, Northridge (CSUN)
Who cannot join
- Taking blood pressure or sleep medication; or already currently practicing a daily meditation.
Trial locations and contacts
1 site in 1 country.
United States1 site
California State University, Northridge
Northridge, California, 91330-8411
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- Meditation Group
- Keywords
- Student Stress, Meditation, Sleep Quality, Blood Pressure
- Medical subject headings
- Stress, Psychological, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation GroupBehavioural
twice daily 20 minute mantra-based meditation practice for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure
Omron HEM 907XL professional automatic blood pressure monitor used at baseline and at 8 weeks post intervention
Measured: 8 weeks
Change in Perceived Stress Survey Questionnaire
10-Item standardized survey tool for perceived stress level
Measured: 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)
Measured: survey at baseline, 1 month and at conclusion of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Northridge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth J Phillips, PT, DPA, Principal investigator, Full Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821611
- Sponsor's protocol ID
- 1314-136-b
- Status last verified
- Feb 2019
- First submitted
- 18 Apr 2016
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapist Doctoral Student Stress Levels and Management Through Meditation
- ClinicalTrials.gov ID
- NCT02821611
- Acronym / sponsor ID
- 1314-136-b
- Conditions
- Stress, Psychological
- Keywords
- Student Stress, Meditation, Sleep Quality, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- California State University, NorthridgeUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Group | Experimental | Behavioral: Meditation GroupParticipants 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 | No intervention | –Control group participants will continue their normal activities and not add any form of meditation during the study period. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Graduate student in the first year of the Doctorate of Physical Therapy (DPT) program at California State University, Northridge (CSUN)
Key exclusion criteria (1 listed)
- Taking blood pressure or sleep medication; or already currently practicing a daily meditation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation Grouptwice daily 20 minute mantra-based meditation practice for 8 weeks | Behavioural | Meditation Group |
Primary outcome
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth J Phillips, PT, DPA principal investigator
Full Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation Group in people with Stress, Psychological, run by California State University, Northridge at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.