Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Meditation Practice in Pediatric Healthcare Professionals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02947074
Recruitment Status : Unknown
Verified October 2016 by Danilo Forghieri Santaella, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Danilo Forghieri Santaella, University of Sao Paulo

Brief Summary:

Rationale: Healthcare professionals face a growing burden of responsibilities and work overload which may cause psychological suffering expressed by burnout, depression and other negative psychological variables. Personal behavioral strategies may facilitate the coping process. To maintain these positive characteristics, it is necessary that one decouples from automatic thoughts, habits and patterns of unhealthy behaviors, leading to behavioral and physiological regulation, through mindfulness techniques. More specifically, Yoga is an ancient Indian philosophical and practical system and its ultimate goal is to calm the human mind, and increase vital capabilities. In addition to the ethical precepts of Yoga, practices involve asanas (postures), pranayama (breathing exercises) and dhyana (meditation). Many studies have shown the positive effects of Yoga and meditation on psychometric variables, however, there are few which address the effectiveness of Yoga on improving psychometric variables of health care professionals. Thus, aiming to reduce the symptoms that health care professionals experience when they are under burnout, this study intends to use Yoga meditation, which may enable the professional to experience decoupling of harmful feelings, improving, firstly, one's own inner self-relationship and therefore, with patients and their families.

Objective: To investigate the effects of a 8-week yoga meditation program on psychometric and physiological variables of Pediatrics health professionals.

Methods: randomized controlled clinical trial. Participants: 60 health professionals from the Pediatrics Department of a tertiary hospital from Federal University of São Paulo (UNIFESP) will be randomized to meditation or control (waiting list) groups. Subjects of the meditation groups will have 2 30 min classes a week.

Evaluations: Psychometric and physiological variables will be accessed at study entry (baseline) and after its completion (8-weeks).

Statistical Analysis: mixed general linear model (intervenient factors: groups - meditation vs. control and moment - baseline vs. 8-weeks). Significance accepted with p<0.05.


Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: Yoga Meditation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Meditation Practice in Pediatric Healthcare Professionals: a Randomized Controlled Clinical Trial
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Waiting list
Experimental: Yoga Meditation
Previously naive to yoga and meditation, subjects will receive 2 30min yoga meditation classes for 8 weeks.
Behavioral: Yoga Meditation
Briefly, subjects will be taught to progressively drive their attention to their inner-self, and keep a calm, nonjudgmental and observational approach towards their own thoughts for 30 minutes.




Primary Outcome Measures :
  1. Change in Glutathione from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    Spectrometry


Secondary Outcome Measures :
  1. Change in Catecholamines from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    HPLC

  2. Change in Serotonin from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    Elisa

  3. Change in Burnout from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    MBI-HSS

  4. Change in Resilience from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    BRCS

  5. Change in Self-compassion from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    SCS

  6. Change in Subjective well-being from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    EBE

  7. Change in Quality of life from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    WHOQOL - BREF

  8. Change in Mindfulness from baseline to 8 weeks [ Time Frame: Baseline and 8-weeks ]
    MAAS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults
  • both genders
  • naive to yoga
  • naive to meditation

Exclusion Criteria:

  • diagnosed with psychiatric/cognitive disorder
  • taking any medication which might bias the evaluation process
  • illiterate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947074


Contacts
Layout table for location contacts
Contact: Danilo F Santaella, Ph.D. (5511)981510444 danyoga@gmail.com

Locations
Layout table for location information
Brazil
UNIFESP Recruiting
São Paulo, Brazil, 04121-001
Contact: Priscilla C Guerra, Master    5511 5574-7627    pri.c.guerra@hotmail.com   
Sponsors and Collaborators
Danilo Forghieri Santaella
Federal University of São Paulo
Investigators
Layout table for investigator information
Principal Investigator: Priscilla C Guerra, Master Federal University of São Paulo
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Danilo Forghieri Santaella, Ph.D., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02947074    
Other Study ID Numbers: 50822215.9.0000.5505:
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Danilo Forghieri Santaella, University of Sao Paulo:
Yoga
Meditation
Glutathione
Catecholamine
polysomnography
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress, Psychological
Behavioral Symptoms