Clinical trial NCT02947074: Meditation Practice in Pediatric Healthcare Professionals
Official title: Meditation Practice in Pediatric Healthcare Professionals: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Keywords: Yoga
Meditation
Glutathione
Catecholamine
polysomnography
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2016-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in Glutathione from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
Secondary outcomes:
measure: Change in Catecholamines from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change in Serotonin from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change in Burnout from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change in Resilience from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change in Self-compassion from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change in Subjective well-being from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change in Quality of life from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
measure: Change in Mindfulness from baseline to 8 weeks
timeFrame: Baseline and 8-weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UNIFESP
Study officials:
affiliation: Federal University of São Paulo
name: Priscilla C Guerra, Master
role: PRINCIPAL_INVESTIGATOR
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