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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
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. at least 3 month history of non-healing wounds, affecting lower extremities
  2. 55 years

Exclusion criteria:

  1. claustrophobia
  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

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

First Posted
September 14, 2018
Last Updated
December 13, 2019
Sponsor
University Health Network, Toronto
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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
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Results Reference
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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.
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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.
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The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds

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