Recruiting

Meditation & Hyperbaric Oxygen Therapy

Sponsor:

University Health Network, Toronto

Code:

NCT03674749

Conditions

Wound

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Meditation and Hyperbaric Oxygen Treament

Study Details

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

Study ID

NCT03674749

Start date

Sep 10, 2018

Status verified date

Dec, 2019

Completion date

Sep 30, 2020

Anticipated

Primary completion date

Mar 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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

experimental: 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,

Interventions

Meditation and Hyperbaric Oxygen Treament

Meditation sessions will be combined with hyperbaric oxygen treatment

Primary outcome measure

  • Number of patients finishing the study protocol. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Rita Katznelson, MD, FRCPC

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

Ray Janisse

ray.janisse@uhn.ca

Locations

Rouge Valley Medical Centre

Recruiting

Toronto, Ontario, Canada, M1E 4B9

Contacts

Anton Marinov, MD

a.marinov@utoronto.ca

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Rita Katznelson, MD

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 16, 2019

Last verified

Dec, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2019-12-16.