Using a Technology-based Meditation Program Administered Through the iom2 Biofeedback Device to Reduce Depression and Anxiety and Improve QOL in the Inpatient Stroke Rehabilitation Setting

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to investigate the impact of a technology-based meditation program in the inpatient stroke population. It will explore how this approach can support patient-centred, holistic, compassionate care by reducing symptoms of depression and anxiety and improving quality of life. Patients will be recruited from the inpatient stroke rehabilitation unit and will have sustained a stroke in the past 2 months. The main question\[s\] it aims to answer are: 1. Is using a technology-based meditation program in the prevention and/or improvement of post stroke depression and anxiety effective for inpatient stroke survivors? 2. Does using a technology-based meditation program support patient-centered, holistic and compassionate care and result in improved measures of quality of life? Those in the treatment arm will be asked to complete the following: * complete an outcome survey on admission and discharge * participate in meditation therapy at least three times per week for a minimum of 10 minutes per session. Participate in education and demonstration of the meditation app and use of the iom2 device * use the iom2 (technology supported meditation and biofeedback) device to monitor heart rate variability and resonance scores * participate in an informal discussion re: experience with software and biofeedback In this randomized controlled trial, those allocated to the control group (standard care) will undergo their usual inpatient rehabilitation but will be asked to complete the outcome measures on admission and prior to hospital discharge. To maximize data collection, we will offer qualitative interviews with patients and focus groups with staff to understand the perceived benefits of meditation technology for stroke patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Adult (18 years and older)

• Inpatient rehabilitation patients at St. John's Rehab

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

• Identified as being at risk for depression and/or anxiety based on their scores on study screening tools

• Able to comply with study requirements

Locations
Other Locations
Canada
St. John's Rehab
RECRUITING
Toronto
Contact Information
Primary
Amanda Ratner, M.H.Sc.
amanda.ratner@sunnybrook.ca
416-226-6780
Backup
Eva Cohen, B.Sc.
eva.cohen@sri.utoronto.ca
416-226-6780
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2024-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Technology Supported Meditation
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.
Active_comparator: Standard Treatment
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.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: Sunnybrook Research Institute

This content was sourced from clinicaltrials.gov