Meditation and Biofeedback to Improve Anxiety, Depression and Quality of Life in Inpatients After Stroke
NCT ID: NCT05845541
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-01
2024-11-30
Brief Summary
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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.
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Detailed Description
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For those participants who are 'at risk' for depression or anxiety, the following participant characteristics will be collected: age, sex, type of stroke, location of stroke, date of stroke, visual neglect, presence/type of aphasia, The Functional Independence Measure Scores (FIM) (FIMSM; Uniform Data Set for Medical Rehabilitation, 1996), and the Montreal Cognitive Assessment (MOCA) score (Nassredine et al., 2005). These measures are collected as part of routine standard care for all patients and will be obtained from the participants' charts. Self-identified gender will be obtained via an outcome survey measure administered to the participants at baseline and post-intervention.
A simple randomization method will be used to allocate participants to either the treatment arm or control arm of the study. This randomization will be done prior to start of the study whereby an online randomizer will be used to determine group allocation. A person not involved in the data collection or analysis of the findings will be responsible for generating the randomization sequence (to start with treatment or to start with standard care), and will be blinded to which participants are allocated to which group. Since it is impossible to blind the study participants, we will request they not discuss their group allocation with the coordinator who is collecting the outcome measure data, but it is possible they may inadvertently reveal this to the coordinator. Consequently, this will serve to inform the feasibility of blinding study staff for a future trial. If the staff becomes unblinded, we will make a note and the coordinator will continue to collect data. However, the person analyzing the survey data will be blinded to group allocation (group 1 versus group 2) only.
For those allocated to the control group (standard care), they will undergo their inpatient rehabilitation but will be asked to complete the outcome measures again prior to hospital discharge.
For those allocated to the treatment arm (iom2 - technology supported meditation), participants 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. At their first treatment visit, the participants will be provided education about the study and will be given a brief and simple explanation and demonstration of the meditation App (Journeys). As well, they will be given an overview of the study technology with the patient using simple language and a Guided demonstration of the "Journeys" app and the iom2 device. All participants' will be given the opportunity to ask questions and receive additional support where required. It is expected that participants will be able to engage in these sessions independently but study personnel will be available at the beginning and end of each session to ensure accurate use of the technology, data collection and respond to any questions. During and following each session, participants will be shown their average HRV (Heart Rate Variability) score, average HRV, and time spent on the session. Patients will be able to review sessions and keep track of their progress. Participants in the intervention arm will be asked to complete the outcome measures prior to their hospital discharge. As well, an informal discussion about the patient's experience using technology based meditation will be transcribed. All participants will be thanked for their time on the study and will be provided with a $25 gift card.
Participants will be asked if they are interested in a qualitative interview and staff will be asked if they are interested in participating in a focus group. These additional data collection measures will optimize our understanding of the perceived benefits and barriers to using meditation technology for stroke patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
Technology Supported Meditation and Biofeedback
Patient's in the treatment arm will participate in technology based meditation using the iom2 and Journeys app at least 3 times/ week. This will involve placing a probe on their ear attached to the iom2 and following the guidance provided by the Journeys App.
During and following each session, participants will be shown their average heart rate variability (HRV) score, average HRV, and time spent on the session. Patients will be able to review sessions and keep track of their progress. Participants in the intervention arm will be asked to complete the outcome measures prior to their hospital discharge. As well, an informal discussion about the patient's experience using technology based meditation will be transcribed.
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.
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.
Interventions
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Technology Supported Meditation and Biofeedback
Patient's in the treatment arm will participate in technology based meditation using the iom2 and Journeys app at least 3 times/ week. This will involve placing a probe on their ear attached to the iom2 and following the guidance provided by the Journeys App.
During and following each session, participants will be shown their average heart rate variability (HRV) score, average HRV, and time spent on the session. Patients will be able to review sessions and keep track of their progress. Participants in the intervention arm will be asked to complete the outcome measures prior to their hospital discharge. As well, an informal discussion about the patient's experience using technology based meditation will be transcribed.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Significant comorbidity including psychiatric or neurological disorder (not including premorbid depression or anxiety)
* Inability to complete any of the outcome measures
* Starting a new antidepressant or a change in antidepressant medication within the past 6 months
* Inability to provide informed consent
* For qualitative interviews, patients can have experienced a stroke within one year.
* For focus groups, staff who work significantly with stroke patients at St. John's Rehab. Staff can be physicians, nurses, allied health.
18 Years
ALL
Yes
Sponsors
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Sunnybrook Research Institute
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Amanda Ratner, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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St. John's Rehab
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5628
Identifier Type: -
Identifier Source: org_study_id
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