Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02947074
Status:
UNKNOWN
Last Update Posted:
2016-10-27
First Post:
2016-10-06
Brief Title:
Meditation Practice in Pediatric Healthcare Professionals
Sponsor:
Danilo Forghieri Santaella
Organization:
University of Sao Paulo
Study Overview
Official Title:
Meditation Practice in Pediatric Healthcare Professionals a Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ones 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 p005
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 p005
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 ones 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 psychiatriccognitive 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 p005
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
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 psychiatriccognitive 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 p005
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None