Meditation Practice in Pediatric Healthcare Professionals

NCT02947074 | Unknown

• 1 other identifier: 50822215.9.0000.5505:
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Keywords

Yoga; Meditation; Glutathione; Catecholamine; polysomnography

Outcome Measures

Primary Outcomes (1)

• Change in Glutathione from baseline to 8 weeks

  Spectrometry

  Baseline and 8-weeks

Secondary Outcomes (8)

• Change in Catecholamines from baseline to 8 weeks

  Baseline and 8-weeks

• Change in Serotonin from baseline to 8 weeks

  Baseline and 8-weeks

• Change in Burnout from baseline to 8 weeks

  Baseline and 8-weeks

• Change in Resilience from baseline to 8 weeks

  Baseline and 8-weeks

• Change in Self-compassion from baseline to 8 weeks

  Baseline and 8-weeks

Study Arms (2)

Control

NO INTERVENTION

Waiting list

Yoga Meditation

EXPERIMENTAL

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

Behavioral: Yoga Meditation

Interventions

Yoga Meditation BEHAVIORAL

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.

Yoga Meditation

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Danilo Forghieri Santaella: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

UNIFESP

São Paulo, São Paulo, 04121-001, Brazil

RECRUITING

Related Publications (10)

• 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.

  PMID: 27396776 BACKGROUND

• 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.

  PMID: 27262013 BACKGROUND

• 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. doi: 10.1016/j.brainresprot.2004.09.002.

  PMID: 15519952 BACKGROUND

• 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.

  PMID: 23081977 BACKGROUND

• 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.

  PMID: 20167507 BACKGROUND

• 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. Epub 2011 Jan 19.

  PMID: 21254062 BACKGROUND

• 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.

  PMID: 24395196 BACKGROUND

• 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.

  PMID: 19361005 BACKGROUND

• 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):e003682. doi: 10.1161/JAHA.116.003682.

  PMID: 27609361 BACKGROUND

• Guerra PC, Santaella DF, D'Almeida V, Santos-Silva R, Tufik S, Len CA. Yogic meditation improves objective and subjective sleep quality of healthcare professionals. Complement Ther Clin Pract. 2020 Aug;40:101204. doi: 10.1016/j.ctcp.2020.101204. Epub 2020 May 30.

  PMID: 32891281 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Priscilla C Guerra, Master

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danilo F Santaella, Ph.D.

CONTACT

(5511)981510444; danyoga@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 27, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)