Peripheral Vascular Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMeditation
Guided meditation utilizing breath awareness, body scan and visualization techniques
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
The proceduralists that will be performing the peripheral vascular interventions will be blinded to the group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Undergoing an endovascular procedure for peripheral vascular disease * Anesthesia plan for procedural sedation and analgesia
Exclusion criteria
* Pre-existing psychiatric disorder such as anxiety, panic disorder, depression, psychosis, or bipolar disorder * Non-English speaking * Prior history of ipsilateral lower extremity amputation * Urgent or Emergent Surgery * Anesthesia plan for general anesthesia * Undergoing a hybrid procedure (simultaneous endovascular and open surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Implementing Preoperative Guided Meditation | Immediately before surgery | Feasibility will be defined as \>80% of the patients enrolled in the intervention arm having successfully completed both rounds of perioperative meditation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety - STAI-6 | Preoperative (prior to meditation) | 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. |
| Interoceptive Attention - MAIA (Noticing Sub Scale) | Preoperative (prior to meditation) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Control Group Standard of care, which does not involve any meditation programs | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | index procedure changed to an open surgical procedure that required general anesthesia. | 0 | 1 |
Baseline characteristics
| Characteristic | Control Group | Total | Meditation Group |
|---|---|---|---|
| Age, Continuous | 72.3 years STANDARD_DEVIATION 9.05 | 71.5 years STANDARD_DEVIATION 12.1 | 70.8 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 30 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PROMIS-10 Score | 10.2 score STANDARD_DEVIATION 2.42 | 9.8 score STANDARD_DEVIATION 2.38 | 9.4 score STANDARD_DEVIATION 2.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 26 Participants | 14 Participants |
| Region of Enrollment United States | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 6 Participants |
| Sex: Female, Male Male | 12 Participants | 21 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
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.
Time frame: Immediately before surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Meditation Group | Feasibility of Implementing Preoperative Guided Meditation | 15 Participants |
| Control Group | Feasibility of Implementing Preoperative Guided Meditation | 14 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.
Time frame: Preoperative (prior to meditation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Anxiety - STAI-6 | 11.93 units on a scale | Standard Deviation 4.43 |
| Control Group | Anxiety - STAI-6 | 11.86 units on a scale | Standard Deviation 3.94 |
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.
Time frame: Postoperative (within 6 hours after surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Anxiety - STAI-6 | 8.33 units on a scale | Standard Deviation 2.22 |
| Control Group | Anxiety - STAI-6 | 9.42 units on a scale | Standard Deviation 3.39 |
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.
Time frame: Preoperative (prior to meditation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Interoceptive Attention - MAIA (Noticing Sub Scale) | 12.8 units on a scale | Standard Deviation 5.08 |
| Control Group | Interoceptive Attention - MAIA (Noticing Sub Scale) | 10.7 units on a scale | Standard Deviation 4.87 |
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.
Time frame: Postoperative (within 6 hours after surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Interoceptive Attention - MAIA (Noticing Sub Scale) | 14.3 units on a scale | Standard Deviation 4.46 |
| Control Group | Interoceptive Attention - MAIA (Noticing Sub Scale) | 11.5 units on a scale | Standard Deviation 4.92 |