Meditation Practice in Pediatric Healthcare Professionals

Stress, Psychological Clinical Trial

Official title:

Meditation Practice in Pediatric Healthcare Professionals: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02947074
• Other study ID #: 50822215.9.0000.5505:
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2016
• Last updated: October 26, 2016
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: October 2016
• Source: University of Sao Paulo
• Contact: Danilo F Santaella, Ph.D.
• Phone: (5511)981510444
• Email: danyoga[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Brazil	UNIFESP	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Danilo Forghieri Santaella	Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008 Dec 10;(12):1-23. — View Citation

Blackwelder R, Watson KH, Freedy JR. Physician Wellness Across the Professional Spectrum. Prim Care. 2016 Jun;43(2):355-61. doi: 10.1016/j.pop.2016.01.004. Review. — View Citation

Cardoso R, de Souza E, Camano L, Leite JR. Meditation in health: an operational definition. Brain Res Brain Res Protoc. 2004 Nov;14(1):58-60. Review. — View Citation

Chiesa A, Malinowski P. Mindfulness-based approaches: are they all the same? J Clin Psychol. 2011 Apr;67(4):404-24. doi: 10.1002/jclp.20776. — View Citation

Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018. Review. — View Citation

Moss M, Good VS, Gozal D, Kleinpell R, Sessler CN. An Official Critical Care Societies Collaborative Statement-Burnout Syndrome in Critical Care Health-care Professionals: A Call for Action. Chest. 2016 Jul;150(1):17-26. doi: 10.1016/j.chest.2016.02.649. — View Citation

Pastori D, Pignatelli P, Farcomeni A, Menichelli D, Nocella C, Carnevale R, Violi F. Aging-Related Decline of Glutathione Peroxidase 3 and Risk of Cardiovascular Events in Patients With Atrial Fibrillation. J Am Heart Assoc. 2016 Sep 8;5(9). pii: e003682. doi: 10.1161/JAHA.116.003682. — View Citation

Tang YY, Posner MI. Tools of the trade: theory and method in mindfulness neuroscience. Soc Cogn Affect Neurosci. 2013 Jan;8(1):118-20. doi: 10.1093/scan/nss112. Epub 2012 Oct 18. — View Citation

Travis F, Shear J. Focused attention, open monitoring and automatic self-transcending: Categories to organize meditations from Vedic, Buddhist and Chinese traditions. Conscious Cogn. 2010 Dec;19(4):1110-8. doi: 10.1016/j.concog.2010.01.007. Epub 2010 Feb 18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glutathione from baseline to 8 weeks	Spectrometry	Baseline and 8-weeks	No
Secondary	Change in Catecholamines from baseline to 8 weeks	HPLC	Baseline and 8-weeks	No
Secondary	Change in Serotonin from baseline to 8 weeks	Elisa	Baseline and 8-weeks	No
Secondary	Change in Burnout from baseline to 8 weeks	MBI-HSS	Baseline and 8-weeks	No
Secondary	Change in Resilience from baseline to 8 weeks	BRCS	Baseline and 8-weeks	No
Secondary	Change in Self-compassion from baseline to 8 weeks	SCS	Baseline and 8-weeks	No
Secondary	Change in Subjective well-being from baseline to 8 weeks	EBE	Baseline and 8-weeks	No
Secondary	Change in Quality of life from baseline to 8 weeks	WHOQOL - BREF	Baseline and 8-weeks	No
Secondary	Change in Mindfulness from baseline to 8 weeks	MAAS	Baseline and 8-weeks	No