Clinical trial NCT03674749: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Wound
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients finishing the study protocol.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Rouge Valley Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
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