The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds
Primary Purpose
Wound
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Meditation and Hyperbaric Oxygen Treament
Sponsored by
About this trial
This is an interventional treatment trial for Wound
Eligibility Criteria
Inclusion criteria:
- at least 3 month history of non-healing wounds, affecting lower extremities
- 55 years
Exclusion criteria:
- claustrophobia
- seizure disorder
- active asthma
- severe chronic obstructive pulmonary disease
- history of pneumothorax
- history of severe congestive heart failure with left ventricular ejection fraction < 25%
- unstable angina
- chronic or acute otitis media or major ear drum trauma
- current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
- recent relapse of depression, psychosis, schizophrenia, hallucinations, suicidal thoughts
Sites / Locations
- Rouge Valley Medical CentreRecruiting
- Toronto General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Hyperbaric Oxygen
Meditation with Hyperbaric Oxygen
Arm Description
Hyperbaric oxygen treatment with 100% oxygen at 2.0 ATA for 90 min, once daily, five times a week for 8 consecutive weeks
Meditation session combined with each hyperbaric oxygen treatment with 100% oxygen at 2.0 ATA for 90 min, once daily, five times a week for 8 consecutive weeks,
Outcomes
Primary Outcome Measures
Number of patients finishing the study protocol.
Secondary Outcome Measures
Full Information
NCT ID
NCT03674749
First Posted
September 14, 2018
Last Updated
December 13, 2019
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03674749
Brief Title
The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds
Official Title
Effect of Meditation and Hyperbaric Oxygen Therapy on Cognition, Healing Process and Overall Well-being in Elderly Patients With Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In Ontario, wound care support has steadily increased over the years. With the growth of the aging population, the financial and psychological burden related to wound care will continue to rise. Studies have shown that structured meditation programs can improve on the recovery process for both physical and psychological disease. Therapeutic treatments like Hyperbaric Oxygen Therapy (HBOT) for chronic wounds have shown to promote angiogenesis, cerebral blood and neuroplasticity in patients with stroke, traumatic brain injury and chronic pain. By combining meditation and HBOT, this have been independently shown to improve healing and reducing costs associated with chronic wounds.
Detailed Description
Each year, Community Care Access Centers (CCAC) provide long-term wound care for over 22,000 patients in Ontario, with numbers steadily increasing with the aging population. In Ontario, the cost of community care for lower leg ulcers has been estimated at over $500 million per year. This does not include the additional cost of adjunctive HBOT, which averages over $120 thousand for a standard 40 treatment course. These costs are further compounded by the psychological comorbidities that often accompany chronic disease, although these numbers are difficult to capture. Across Canada, the health burden cost of anxiety and depression alone totals over $14 billion annually, with disability costs comparable to those associated with heart disease. Furthermore, recent evidence suggests that psychological interventions are more cost-effective than drug treatment, with comparable results.
The elderly patients with chronic non-healing wounds experience a sense of powerlessness and loss of autonomy that profoundly impacts subjective wellbeing. These psychological effects in turn compromise healing, as growing evidence suggests that psychological stress impacts wound repair [1, 2]. Recent studies have shown that structured meditation programs can improve recovery from both physical and psychological disease. For example, meditation enhances immune response [3, 4] while reducing blood pressure [5], insulin resistance [6], oxidative stress [7], inflammation [8], and other risk indices. Furthermore, meditation therapy can be broadly applied with few limitations, having successfully been used in elderly [9], ill [10] and disabled [11] populations.
Hyperbaric oxygen therapy (HBOT) is an adjuvant therapy for chronic wounds. HBOT increases oxygen delivery to tissues via inhalation of 100% oxygen at high barometric pressures. HBOT has been shown to promote angiogenesis, cerebral blood and neuroplasticity in patients with stroke, traumatic brain injury and chronic pain. Furthermore, HBOT also alleviates inflammation, reduces oxidative stress, inhibits apoptosis and stimulates signaling pathways essential for wound healing.
Patients referred for HBOT assessment often have "problem wounds" that have failed prolonged courses of standard wound care. These refractory wounds may benefit from a multimodal approach that targets both the physical and psychological manifestations of chronic disease. Meditation is a simple and economical addition to HBOT that may further enhance the rate of healing by alleviating psychological stressors. Meditation encompasses a spectrum of mindfulness-based interventions that have been shown to improve mental and physical health in randomized trials. Meditation reduces stress, pain, anxiety, depression and blood pressure while improving cognition and memory performance. A variety of specialties have begun to use meditation as a cost-effective, low-stigma adjunct to standard medical and psychiatric care.
Meditation and HBOT have been independently shown to improve healing, and may have synergistic effects when applied together. This combined intervention has the potential to improve mood while enhancing the healing process, offering improved health while reducing the costs associated with chronic wounds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric Oxygen
Arm Type
Active Comparator
Arm Description
Hyperbaric oxygen treatment with 100% oxygen at 2.0 ATA for 90 min, once daily, five times a week for 8 consecutive weeks
Arm Title
Meditation with Hyperbaric Oxygen
Arm Type
Experimental
Arm Description
Meditation session combined with each hyperbaric oxygen treatment with 100% oxygen at 2.0 ATA for 90 min, once daily, five times a week for 8 consecutive weeks,
Intervention Type
Other
Intervention Name(s)
Meditation and Hyperbaric Oxygen Treament
Intervention Description
Meditation sessions will be combined with hyperbaric oxygen treatment
Primary Outcome Measure Information:
Title
Number of patients finishing the study protocol.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
at least 3 month history of non-healing wounds, affecting lower extremities
55 years
Exclusion criteria:
claustrophobia
seizure disorder
active asthma
severe chronic obstructive pulmonary disease
history of pneumothorax
history of severe congestive heart failure with left ventricular ejection fraction < 25%
unstable angina
chronic or acute otitis media or major ear drum trauma
current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
recent relapse of depression, psychosis, schizophrenia, hallucinations, suicidal thoughts
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Katznelson, MD, FRCPC
Phone
416-340-4800
Ext
6273
Email
rita.katznelson@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ray Janisse
Email
ray.janisse@uhn.ca
Facility Information:
Facility Name
Rouge Valley Medical Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1E 4B9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Marinov, MD
Email
a.marinov@utoronto.ca
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Katznelson, MD
Phone
416-340-4800
Ext
6273
Email
rita.katznelson@uhn.ca
12. IPD Sharing Statement
Citations:
PubMed Identifier
14508033
Citation
Broadbent E, Petrie KJ, Alley PG, Booth RJ. Psychological stress impairs early wound repair following surgery. Psychosom Med. 2003 Sep-Oct;65(5):865-9. doi: 10.1097/01.psy.0000088589.92699.30.
Results Reference
background
PubMed Identifier
21094925
Citation
Gouin JP, Kiecolt-Glaser JK. The impact of psychological stress on wound healing: methods and mechanisms. Immunol Allergy Clin North Am. 2011 Feb;31(1):81-93. doi: 10.1016/j.iac.2010.09.010.
Results Reference
background
PubMed Identifier
12883106
Citation
Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, Urbanowski F, Harrington A, Bonus K, Sheridan JF. Alterations in brain and immune function produced by mindfulness meditation. Psychosom Med. 2003 Jul-Aug;65(4):564-70. doi: 10.1097/01.psy.0000077505.67574.e3.
Results Reference
background
PubMed Identifier
18835662
Citation
Pace TW, Negi LT, Adame DD, Cole SP, Sivilli TI, Brown TD, Issa MJ, Raison CL. Effect of compassion meditation on neuroendocrine, innate immune and behavioral responses to psychosocial stress. Psychoneuroendocrinology. 2009 Jan;34(1):87-98. doi: 10.1016/j.psyneuen.2008.08.011. Epub 2008 Oct 4.
Results Reference
background
PubMed Identifier
22518287
Citation
Goldstein CM, Josephson R, Xie S, Hughes JW. Current perspectives on the use of meditation to reduce blood pressure. Int J Hypertens. 2012;2012:578397. doi: 10.1155/2012/578397. Epub 2012 Mar 5.
Results Reference
background
PubMed Identifier
16772250
Citation
Paul-Labrador M, Polk D, Dwyer JH, Velasquez I, Nidich S, Rainforth M, Schneider R, Merz CN. Effects of a randomized controlled trial of transcendental meditation on components of the metabolic syndrome in subjects with coronary heart disease. Arch Intern Med. 2006 Jun 12;166(11):1218-24. doi: 10.1001/archinte.166.11.1218.
Results Reference
background
PubMed Identifier
21280542
Citation
Mahagita C. Roles of meditation on alleviation of oxidative stress and improvement of antioxidant system. J Med Assoc Thai. 2010 Nov;93 Suppl 6:S242-54.
Results Reference
background
PubMed Identifier
28670311
Citation
Buric I, Farias M, Jong J, Mee C, Brazil IA. What Is the Molecular Signature of Mind-Body Interventions? A Systematic Review of Gene Expression Changes Induced by Meditation and Related Practices. Front Immunol. 2017 Jun 16;8:670. doi: 10.3389/fimmu.2017.00670. eCollection 2017.
Results Reference
background
PubMed Identifier
24571182
Citation
Gard T, Holzel BK, Lazar SW. The potential effects of meditation on age-related cognitive decline: a systematic review. Ann N Y Acad Sci. 2014 Jan;1307:89-103. doi: 10.1111/nyas.12348.
Results Reference
background
PubMed Identifier
14650573
Citation
Bonadonna R. Meditation's impact on chronic illness. Holist Nurs Pract. 2003 Nov-Dec;17(6):309-19. doi: 10.1097/00004650-200311000-00006.
Results Reference
background
PubMed Identifier
15264508
Citation
Squier S. Meditation, disability, and identity. Lit Med. 2004 Spring;23(1):23-45; discussion 61-5. doi: 10.1353/lm.2004.0012. No abstract available.
Results Reference
background
Citation
Harris C, Bates-Jensen B. et al. ,The Bates-Jensen Wound Assessment Tool (BWAT): Development of a Pictorial Guide for Training Nurses. Wound Care Canada, 2009, 7 (2): p 33-38
Results Reference
background
PubMed Identifier
6668417
Citation
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Results Reference
background
PubMed Identifier
28446889
Citation
Scarpina F, Tagini S. The Stroop Color and Word Test. Front Psychol. 2017 Apr 12;8:557. doi: 10.3389/fpsyg.2017.00557. eCollection 2017.
Results Reference
background
PubMed Identifier
20332060
Citation
Geisser ME, Clauw DJ, Strand V, Gendreau MR, Palmer R, Williams DA. Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran. Pain. 2010 May;149(2):373-378. doi: 10.1016/j.pain.2010.02.043. Epub 2010 Mar 23.
Results Reference
background
PubMed Identifier
6880820
Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Results Reference
background
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The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds
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