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Meditation Practice in Pediatric Healthcare Professionals

Primary Purpose

Stress, Psychological

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Yoga Meditation
Sponsored by
Danilo Forghieri Santaella
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress, Psychological focused on measuring Yoga, Meditation, Glutathione, Catecholamine, polysomnography

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UNIFESPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Yoga Meditation

Arm Description

Waiting list

Previously naive to yoga and meditation, subjects will receive 2 30min yoga meditation classes for 8 weeks.

Outcomes

Primary Outcome Measures

Change in Glutathione from baseline to 8 weeks
Spectrometry

Secondary Outcome Measures

Change in Catecholamines from baseline to 8 weeks
HPLC
Change in Serotonin from baseline to 8 weeks
Elisa
Change in Burnout from baseline to 8 weeks
MBI-HSS
Change in Resilience from baseline to 8 weeks
BRCS
Change in Self-compassion from baseline to 8 weeks
SCS
Change in Subjective well-being from baseline to 8 weeks
EBE
Change in Quality of life from baseline to 8 weeks
WHOQOL - BREF
Change in Mindfulness from baseline to 8 weeks
MAAS

Full Information

First Posted
October 6, 2016
Last Updated
October 26, 2016
Sponsor
Danilo Forghieri Santaella
Collaborators
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02947074
Brief Title
Meditation Practice in Pediatric Healthcare Professionals
Official Title
Meditation Practice in Pediatric Healthcare Professionals: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Danilo Forghieri Santaella
Collaborators
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. On the other hand, there are individual strategies which may be involved and facilitate the coping process: resilience, self-compassion, subjective well-being, subjective quality of life. In order to maintain these positive characteristics, it is necessary that one may decouple from automatic thoughts, habits and patterns of unhealthy behaviors, leading to behavioral and physiological regulation. There are many mindfulness techniques, which hold in common the following operating parameters: use of a specific technique, clearly defined and regularly practiced; use of muscle relaxation during the process; existence of logical relaxation without the intention of analyzing, judging or creating any expectation about the process. 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, its practices involve asanas (postures), pranayama (breathing exercises) and dhyana (meditation). Therefore, the process must be done in a gradual and progressive manner, from the outermost to the innermost, from the simplest to the most complex - from the body to the mind, with breath as a bridge between them. 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 suffer when they are in burnout, this study intends to use Yoga meditation, which may enable health professionals to experience decoupling of harmful feelings, improving one's own inner self-relationship and therefore, with patients and their families. Primary Objective: To assess whether a 8-week intervention of a yoga meditation program influences psychometric (burnout, resilience, self-compassion, subjective well-being, health related quality of life and mindfulness) and physiological (polysomnography, glutathione, catecholamine and serotonin) variables of Pediatrics health professionals. Secondary Objective: To investigate the cross psychometric profile of Federal University of São Paulo (UNIFESP) Pediatrics professionals at the inception of the program. Methodology Experimental design: randomized controlled clinical trial. Participants: 60 health professionals from the Pediatrics Department of a tertiary hospital from UNIFESP will be randomized to meditation or control (waiting list) groups. At the end of the protocol participants of the control group will be offered the possibility to participate of an identical meditation program. Inclusion criteria: adults; both sexes; not diagnosed with psychiatric/cognitive disorder or taking any medication which might bias the evaluation process. The intervention group will participate in an 8-week course of meditation (2 30-min classes a week). Space: Evaluations and meditation program will be conducted in a quiet room specifically reserved for this training at UNIFESP. Primary outcome: Demonstrate that meditation can be a useful tool in improving burnout, resilience, self-compassion, subjective well-being, quality of life and of health care professionals. Resources: All personnel and logistics necessary for this research will be provided by the Sports Center of the University of São Paulo (CEPEUSP) and UNIFESP. Procedures: Meditation training will follow a weekly stratified plan, through which participants will be guided from the most exterior perceptions, towards the inner most ones, focusing on yoga meditation processes. First week will have relaxation, and easy-to-perform asanas along with introduction to pranayama; second week will have pranayamas and introduction to concentration; from third week onwards, participants will have concentration and meditation as main components of the classes. Evaluation plan: Measurements will be done in two stages: study entry and after 8 weeks. Assessment instruments: burnout (MBI-HSS), resilience (BRCS), self-pity (SCS), subjective well-being (EBE), quality of life (WHOQOL BREF), attention and mindfulness (MAAS) scales; venous puncture (by a nurse from Clinical Studies Development Centre Brazil) - 20ml of blood for glutathione, catecholamine and serotonin analysis; polysomnography (Sleep Institute - São Paulo, Brazil). Statistical Analysis: mixed general linear model (intervenient factors: groups - meditation vs. control and moment - baseline vs. 8-weeks). Significance accepted with p<0.05. Potential impact: Investigators expect to have a great positive impact on health care professionals. Through meditation, participants may improve burnout rates, resilience, self-compassion, subjective well-being, quality of life and mindfulness. Such improvements may improve work environment, work satisfaction, decrease absenteeism and increase the professional-patient relationship. Besides, with positive results, it is possible to try and spread the practice of Yoga to other public hospitals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Yoga, Meditation, Glutathione, Catecholamine, polysomnography

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Waiting list
Arm Title
Yoga Meditation
Arm Type
Experimental
Arm Description
Previously naive to yoga and meditation, subjects will receive 2 30min yoga meditation classes for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Yoga Meditation
Intervention Description
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 Measure Information:
Title
Change in Glutathione from baseline to 8 weeks
Description
Spectrometry
Time Frame
Baseline and 8-weeks
Secondary Outcome Measure Information:
Title
Change in Catecholamines from baseline to 8 weeks
Description
HPLC
Time Frame
Baseline and 8-weeks
Title
Change in Serotonin from baseline to 8 weeks
Description
Elisa
Time Frame
Baseline and 8-weeks
Title
Change in Burnout from baseline to 8 weeks
Description
MBI-HSS
Time Frame
Baseline and 8-weeks
Title
Change in Resilience from baseline to 8 weeks
Description
BRCS
Time Frame
Baseline and 8-weeks
Title
Change in Self-compassion from baseline to 8 weeks
Description
SCS
Time Frame
Baseline and 8-weeks
Title
Change in Subjective well-being from baseline to 8 weeks
Description
EBE
Time Frame
Baseline and 8-weeks
Title
Change in Quality of life from baseline to 8 weeks
Description
WHOQOL - BREF
Time Frame
Baseline and 8-weeks
Title
Change in Mindfulness from baseline to 8 weeks
Description
MAAS
Time Frame
Baseline and 8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danilo F Santaella, Ph.D.
Phone
(5511)981510444
Email
danyoga@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscilla C Guerra, Master
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNIFESP
City
São Paulo
ZIP/Postal Code
04121-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscilla C Guerra, Master
Phone
5511 5574-7627
Email
pri.c.guerra@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27396776
Citation
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Results Reference
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PubMed Identifier
27262013
Citation
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Results Reference
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PubMed Identifier
15519952
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
20167507
Citation
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Results Reference
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PubMed Identifier
21254062
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
derived

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Meditation Practice in Pediatric Healthcare Professionals

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