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| ID | Type | Description | Link |
|---|---|---|---|
| F32HS028943-01 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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The primary purpose of this clinical trial is to test the feasibility of implementing a perioperative guided meditation program for patients undergoing peripheral vascular interventions that are performed under procedural sedation and analgesia.
This is a prospective, randomized, controlled study involving 30 adult patients undergoing peripheral vascular interventions. Patients will be randomized to two arms: an intervention arm where patients will participate in perioperative guided meditation, and a control arm where patients will receive standard of care without any meditation intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditation Group | Experimental | Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery |
|
| Control Group | No Intervention | Standard of care, which does not involve any meditation programs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Behavioral | Guided meditation utilizing breath awareness, body scan and visualization techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Implementing Preoperative Guided Meditation | Feasibility will be defined as >80% of the patients enrolled in the intervention arm having successfully completed both rounds of perioperative meditation. | Immediately before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety - STAI-6 | The State-Trait Anxiety Inventory (STAI) is a patient-reported measure of anxiety. The score range for the STAI-6 is from 6 to 24. Higher scores indicate higher anxiety, and thus are worse. | Preoperative (prior to meditation) |
| Interoceptive Attention - MAIA (Noticing Sub Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chien Yi M Png, MD | Massachusetts General Hospital | Study Chair |
| Chien Yi M Png, MD | Massachusetts General Hospital | Study Director |
| Anahita Dua, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Newton Wellesley Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Meditation Group | Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery Meditation: Guided meditation utilizing breath awareness, body scan and visualization techniques |
| FG001 | Control Group | Standard of care, which does not involve any meditation programs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Meditation Group | Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery Meditation: Guided meditation utilizing breath awareness, body scan and visualization techniques |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Implementing Preoperative Guided Meditation | Feasibility will be defined as >80% of the patients enrolled in the intervention arm having successfully completed both rounds of perioperative meditation. | Posted | Count of Participants | Participants | Immediately before surgery |
|
Adverse event data were collected from the time of enrollment until the completion of the perioperative meditation program.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meditation Group | Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery Meditation: Guided meditation utilizing breath awareness, body scan and visualization techniques |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chien Yi Maximilian Png, MD | Massachusetts General Hospital | 617-726-5308 | cypng@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2024 | Feb 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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The proceduralists that will be performing the peripheral vascular interventions will be blinded to the group allocation.
The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a patient-reported measure of interoceptive attention. Higher scores indicate higher interoception, and thus are better. This sub scale score represented the combined scores of the 4 questions in the noticing sub scale, and ranged from 0 to 20. |
| Preoperative (prior to meditation) |
| Anxiety - STAI-6 | The State-Trait Anxiety Inventory (STAI) is a patient-reported measure of anxiety. The score range for the STAI-6 is from 6 to 24. Higher scores indicate higher anxiety, and thus are worse. | Postoperative (within 6 hours after surgery) |
| Interoceptive Attention - MAIA (Noticing Sub Scale) | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a patient-reported measure of interoceptive attention. Higher scores indicate higher interoception, and thus are better. This sub scale score represented the combined scores of the 4 questions in the noticing sub scale, and ranged from 0 to 20. | Postoperative (within 6 hours after surgery) |
| Newton |
| Massachusetts |
| 02462 |
| United States |
| Salem Hospital | Salem | Massachusetts | 01970 | United States |
| Southern New Hampshire Hospital | Nashua | New Hampshire | 03060 | United States |
Standard of care, which does not involve any meditation programs |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| PROMIS-10 Score | The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health survey is a patient-reported measure of health-related quality of life. The score range for the PROMIS-10 is from 0 to 20. Higher scores indicate higher quality of life, and thus are better. | Mean | Standard Deviation | score |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Anxiety - STAI-6 | The State-Trait Anxiety Inventory (STAI) is a patient-reported measure of anxiety. The score range for the STAI-6 is from 6 to 24. Higher scores indicate higher anxiety, and thus are worse. | Posted | Mean | Standard Deviation | units on a scale | Preoperative (prior to meditation) |
|
|
|
| Secondary | Interoceptive Attention - MAIA (Noticing Sub Scale) | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a patient-reported measure of interoceptive attention. Higher scores indicate higher interoception, and thus are better. This sub scale score represented the combined scores of the 4 questions in the noticing sub scale, and ranged from 0 to 20. | Posted | Mean | Standard Deviation | units on a scale | Preoperative (prior to meditation) |
|
|
|
| Secondary | Anxiety - STAI-6 | The State-Trait Anxiety Inventory (STAI) is a patient-reported measure of anxiety. The score range for the STAI-6 is from 6 to 24. Higher scores indicate higher anxiety, and thus are worse. | Posted | Mean | Standard Deviation | units on a scale | Postoperative (within 6 hours after surgery) |
|
|
|
| Secondary | Interoceptive Attention - MAIA (Noticing Sub Scale) | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a patient-reported measure of interoceptive attention. Higher scores indicate higher interoception, and thus are better. This sub scale score represented the combined scores of the 4 questions in the noticing sub scale, and ranged from 0 to 20. | Posted | Mean | Standard Deviation | units on a scale | Postoperative (within 6 hours after surgery) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control Group | Standard of care, which does not involve any meditation programs | 0 | 14 | 0 | 14 | 0 | 14 |
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| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |