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Meditation and Biofeedback for Stroke Survivors

N/A

Recruiting

Led By Amanda Ratner, M.Sc.

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (18 years and older)

Experienced a stroke within the past two months prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1) pre-intervention: up to 2 weeks before the intervention start date. 2) post-intervention: up to 2 weeks after the intervention end date.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a technology-based meditation program can help inpatient stroke survivors by reducing symptoms of depression and anxiety and improving their quality of life. Patients will be asked to participate in meditation therapy

Who is the study for?

This trial is for adult inpatients at St. John's Rehab who had a stroke within the last two months and are at risk for depression or anxiety, as determined by screening tools. Participants must be able to follow study procedures.

What is being tested?

The trial tests if technology-supported meditation and biofeedback can reduce depression and anxiety, improving quality of life after a stroke. Patients will use an app and device to aid meditation three times weekly, with surveys on admission and discharge.

What are the potential side effects?

Since this intervention involves non-invasive techniques like meditation and biofeedback, side effects may include discomfort from sitting still during sessions or emotional distress if sensitive topics arise during discussions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I had a stroke within the last two months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1) pre-intervention: up to 2 weeks before the intervention start date. 2) post-intervention: up to 2 weeks after the intervention end date.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1) pre-intervention: up to 2 weeks before the intervention start date. 2) post-intervention: up to 2 weeks after the intervention end date.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1) pre-intervention: up to 2 weeks before the intervention start date. 2) post-intervention: up to 2 weeks after the intervention end date. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Anxiety and Depression Scale (HADS)

Stroke Specific Quality of Life Scale (SS-QOL)

The Behavioural Outcomes of Anxiety scale (BOA)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Technology Supported MeditationExperimental Treatment1 Intervention

Patient's randomized to the treatment arm will receive technology-based meditation therapy at least three times per week for a minimum of 10 minutes per session. They will participate in sessions throughout the length of their inpatient stay via the iom2 device and the interactive meditation software. Signals from the iom2 are then sent to an App on a phone, tablet or personal computer that generates biofeedback information and allows patients to adjust their breathing based on the feedback. The interactive Meditation programs teach specific breathing, mindfulness and relaxation techniques to increase a person's heart rate variability (HRV). Doing so provides the participant with instantaneous awareness of their nervous system state, which helps them to learn to directly influence their HRV.

Group II: Standard TreatmentActive Control1 Intervention

Patients at St. John's Rehab undergoing rehabilitation are supported by an interprofessional team - including physiatrists, nurses, occupational therapists, speech language pathologists, physical therapists, social workers and psychiatrists. During their inpatient stay, patients receive a wide range of rehabilitation services aimed at addressing their physical, emotional and cognitive care needs. Length of stay for inpatient services ranges between 2 to 12 weeks.

0 / 2Eligibility criteria met