StressNCT01047917
Meditation to Reduce Stress and Improve Quality of Life
A study testing Meditation DVD in people with Stress, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test a simple meditation program that is easy to learn; inexpensive; easy to practice; non-religion based; and has wide applicability to multiple medical conditions. This program has been developed by the Complementary and Integrative Medicine Program at the Mayo Clinic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Meditation DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Apr 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Good general health
- Access to a DVD player
- Provided with, understand, and have signed the informed consent
Who cannot join
- Are currently using (at the time of enrollment) antipsychotics or recently (< 3 months) started on antidepressants. Patients on stable dose of antidepressant (for ≥ 3 months) will be allowed.
- Have a lifetime history of schizophrenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meditation to Reduce Stress and Improve Quality of Life: A Feasibility Study
The purpose of this study is to test a simple meditation program that is easy to learn; inexpensive; easy to practice; non-religion based; and has wide applicability to multiple medical conditions. This program has been developed by the Complementary and Integrative Medicine Program at the Mayo Clinic.
Read the detailed description
Stress is a ubiquitous problem and a mediator of symptoms for a variety of medical conditions. Most medical diagnoses, procedures, and physician visits are associated with considerable stress. Excessive stress is associated with adverse medical outcomes, unhealthy coping mechanisms, symptoms of anxiety and depression, and overall a poor quality of life. No specific pharmacologic treatment is available for treating stress. Further, it is often difficult or impossible to change the reality of circumstances causing stress in an individual. Thus increasing individual coping mechanisms and ability of a person to handle stress, rather than changing the stressors itself, might be a more feasible approach towards reducing stress.
Meditation is a widely used and increasingly popular intervention that positively affects the individual at cognitive, physical, emotional, behavioral, and spiritual levels. A practice of meditation has been shown to reduce symptoms of stress and improve overall quality of life. Several meditation programs exist, however most are limited by considerable expense, need for elaborate training, lack of widespread availability, or incorporation of ideas and practices unique to a particular culture.
- Conditions
- Stress
- Being tested
- Meditation DVD
- Keywords
- Meditation, Relaxation Therapy, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation DVDBehavioural
Also called Meditation
Participants will undergo a one-hour group instruction session in meditation held by Dr. Amit Sood. Participants will then receive a DVD to practice the intervention at home daily for a total of 4 weeks. The DVD will have 3 different programs of 5, 15, and 30 minutes each loaded on it with a menu option to choose one of the programs.
| Study group | Role | What they receive |
|---|---|---|
| Meditation DVD | Experimental | All participants will receive a Meditation DVD to practice at home daily for a total of 4 weeks. Receives: Behavioral: Meditation DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of incorporating a 4-week innovative meditation program into the daily activities of healthy Mayo Clinic employees for improving stress.
Measured: 4 Weeks
Secondary outcomes (1)
To assess the effect of a 4-week program of meditation on perceived stress and overall quality of life compared to baseline.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dietlind Wahner-Roedler, Mayo Clinic
- Investigators
- Dietlind L. Wahner-Roedler, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047917
- Sponsor's protocol ID
- 07-006601
- Status last verified
- Jan 2012
- First submitted
- 11 Jan 2010
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Prasad K, Wahner-Roedler DL, Cha SS, Sood A. Effect of a single-session meditation training to reduce stress and improve quality of life among health care professionals: a "dose-ranging" feasibility study. Altern Ther Health Med. 2011 May-Jun;17(3):46-9.
PubMed 22164812
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation to Reduce Stress and Improve Quality of Life: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01047917
- Acronym / sponsor ID
- 07-006601
- Conditions
- Stress
- Keywords
- Meditation, Relaxation Therapy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Jan 2010 (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 purpose of this study is to test a simple meditation program that is easy to learn; inexpensive; easy to practice; non-religion based; and has wide applicability to multiple medical conditions. This program has been developed by the Complementary and Integrative Medicine Program at the Mayo Clinic.
Detailed description
Stress is a ubiquitous problem and a mediator of symptoms for a variety of medical conditions. Most medical diagnoses, procedures, and physician visits are associated with considerable stress. Excessive stress is associated with adverse medical outcomes, unhealthy coping mechanisms, symptoms of anxiety and depression, and overall a poor quality of life. No specific pharmacologic treatment is available for treating stress. Further, it is often difficult or impossible to change the reality of circumstances causing stress in an individual. Thus increasing individual coping mechanisms and ability of a person to handle stress, rather than changing the stressors itself, might be a more feasible approach towards reducing stress.
Meditation is a widely used and increasingly popular intervention that positively affects the individual at cognitive, physical, emotional, behavioral, and spiritual levels. A practice of meditation has been shown to reduce symptoms of stress and improve overall quality of life. Several meditation programs exist, however most are limited by considerable expense, need for elaborate training, lack of widespread availability, or incorporation of ideas and practices unique to a particular culture.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meditation DVD | Experimental | Behavioral: Meditation DVDAll participants will receive a Meditation DVD to practice at home daily for a total of 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Good general health
- Access to a DVD player
- Provided with, understand, and have signed the informed consent
Key exclusion criteria (2 listed)
- Are currently using (at the time of enrollment) antipsychotics or recently (< 3 months) started on antidepressants. Patients on stable dose of antidepressant (for ≥ 3 months) will be allowed.
- Have a lifetime history of schizophrenia
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 DVDAlso: MeditationParticipants will undergo a one-hour group instruction session in meditation held by Dr. Amit Sood. Participants will then receive a DVD to practice the intervention at home daily for a total of 4 weeks. The DVD will have 3 different programs of 5, 15, and 30 minutes each loaded on it with a menu option to choose one of the programs. | Behavioural | Meditation DVD |
Primary outcome
To assess the feasibility of incorporating a 4-week innovative meditation program into the daily activities of healthy Mayo Clinic employees for improving stress.
Time frame: 4 Weeks
1 secondary outcome
To assess the effect of a 4-week program of meditation on perceived stress and overall quality of life compared to baseline.
Time frame: 4 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 6 Jan 2012.
- Results publication: PubMed 22164812Prasad K, Wahner-Roedler DL, Cha SS, Sood A. Effect of a single-session meditation training to reduce stress and improve quality of life among health care professionals: a "dose-ranging" feasibility study. Altern Ther Health Med. 2011 May-Jun;17(3):46-9.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Dietlind L. Wahner-Roedler, M.D. principal investigator
Mayo Clinic
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 DVD in people with Stress, run by Mayo Clinic 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 4 inclusion and 2 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 6 Jan 2012. 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?
To assess the feasibility of incorporating a 4-week innovative meditation program into the daily activities of healthy Mayo Clinic employees for improving stress. (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047917, which also lists 1 linked publication.
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 6 Jan 2012.