The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds
NCT ID: NCT03674749
Last Updated: 2019-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-09-10
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hyperbaric Oxygen
Hyperbaric oxygen treatment with 100% oxygen at 2.0 ATA for 90 min, once daily, five times a week for 8 consecutive weeks
Meditation and Hyperbaric Oxygen Treament
Meditation sessions will be combined with hyperbaric oxygen treatment
Meditation with Hyperbaric Oxygen
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,
Meditation and Hyperbaric Oxygen Treament
Meditation sessions will be combined with hyperbaric oxygen treatment
Interventions
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Meditation and Hyperbaric Oxygen Treament
Meditation sessions will be combined with hyperbaric oxygen treatment
Eligibility Criteria
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Inclusion Criteria
2. 55 years
Exclusion Criteria
2. seizure disorder
3. active asthma
4. severe chronic obstructive pulmonary disease
5. history of pneumothorax
6. history of severe congestive heart failure with left ventricular ejection fraction \< 25%
7. unstable angina
8. chronic or acute otitis media or major ear drum trauma
9. current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
10. recent relapse of depression, psychosis, schizophrenia, hallucinations, suicidal thoughts
55 Years
ALL
Yes
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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Rouge Valley Medical Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Anton Marinov, MD
Role: primary
Rita Katznelson, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Bonadonna R. Meditation's impact on chronic illness. Holist Nurs Pract. 2003 Nov-Dec;17(6):309-19. doi: 10.1097/00004650-200311000-00006.
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.
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
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.
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.
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.
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.
Other Identifiers
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18-5271
Identifier Type: -
Identifier Source: org_study_id