The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds

NCT03674749 | Unknown

• 1 other identifier: 18-5271
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• Number of patients finishing the study protocol.

  1 year

Study Arms (2)

Hyperbaric Oxygen

ACTIVE COMPARATOR

Hyperbaric oxygen treatment with 100% oxygen at 2.0 ATA for 90 min, once daily, five times a week for 8 consecutive weeks

Other: Meditation and Hyperbaric Oxygen Treament

Meditation with Hyperbaric Oxygen

EXPERIMENTAL

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,

Other: Meditation and Hyperbaric Oxygen Treament

Interventions

Meditation and Hyperbaric Oxygen Treament OTHER

Meditation sessions will be combined with hyperbaric oxygen treatment

Hyperbaric Oxygen; Meditation with Hyperbaric Oxygen

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 3 month history of non-healing wounds, affecting lower extremities
• years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Rouge Valley Medical Centre

Toronto, Ontario, M1E 4B9, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (16)

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  PMID: 14508033 BACKGROUND

• 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.

  PMID: 21094925 BACKGROUND

• 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.

  PMID: 12883106 BACKGROUND

• 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.

  PMID: 18835662 BACKGROUND

• 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.

  PMID: 22518287 BACKGROUND

• 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.

  PMID: 16772250 BACKGROUND

• 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.

  PMID: 21280542 BACKGROUND

• 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.

  PMID: 28670311 BACKGROUND

• 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.

  PMID: 24571182 BACKGROUND

• Bonadonna R. Meditation's impact on chronic illness. Holist Nurs Pract. 2003 Nov-Dec;17(6):309-19. doi: 10.1097/00004650-200311000-00006.

  PMID: 14650573 BACKGROUND

• 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.

  PMID: 15264508 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 28446889 BACKGROUND

• 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.

  PMID: 20332060 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Rita Katznelson, MD, FRCPC

CONTACT

416-340-4800; rita.katznelson@uhn.ca

Ray Janisse

CONTACT

ray.janisse@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 18, 2018
• Study Start: September 10, 2018
• Primary Completion: March 31, 2020
• Study Completion: September 30, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

CA (2)