Trial Outcomes & Findings for Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery (NCT NCT05837481)
NCT ID: NCT05837481
Last Updated: 2024-10-16
Results Overview
Feasibility will be defined as \>80% of the patients enrolled in the intervention arm having successfully completed both rounds of perioperative meditation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Immediately before surgery
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
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
|
Control Group
Standard of care, which does not involve any meditation programs
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
Control Group
Standard of care, which does not involve any meditation programs
|
|---|---|---|
|
Overall Study
index procedure changed to an open surgical procedure that required general anesthesia.
|
0
|
1
|
Baseline Characteristics
Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery
Baseline characteristics by cohort
| Measure |
Meditation Group
n=15 Participants
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
|
Control Group
n=15 Participants
Standard of care, which does not involve any meditation programs
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
72.3 years
STANDARD_DEVIATION 9.05 • n=7 Participants
|
71.5 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
PROMIS-10 Score
|
9.4 score
STANDARD_DEVIATION 2.35 • n=5 Participants
|
10.2 score
STANDARD_DEVIATION 2.42 • n=7 Participants
|
9.8 score
STANDARD_DEVIATION 2.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately before surgeryFeasibility will be defined as \>80% of the patients enrolled in the intervention arm having successfully completed both rounds of perioperative meditation.
Outcome measures
| Measure |
Meditation Group
n=15 Participants
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
|
Control Group
n=14 Participants
Standard of care, which does not involve any meditation programs
|
|---|---|---|
|
Feasibility of Implementing Preoperative Guided Meditation
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Meditation Group
n=15 Participants
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
|
Control Group
n=15 Participants
Standard of care, which does not involve any meditation programs
|
|---|---|---|
|
Anxiety - STAI-6
|
11.93 units on a scale
Standard Deviation 4.43
|
11.86 units on a scale
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Meditation Group
n=15 Participants
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
|
Control Group
n=15 Participants
Standard of care, which does not involve any meditation programs
|
|---|---|---|
|
Interoceptive Attention - MAIA (Noticing Sub Scale)
|
12.8 units on a scale
Standard Deviation 5.08
|
10.7 units on a scale
Standard Deviation 4.87
|
SECONDARY outcome
Timeframe: Postoperative (within 6 hours after surgery)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.
Outcome measures
| Measure |
Meditation Group
n=15 Participants
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
|
Control Group
n=14 Participants
Standard of care, which does not involve any meditation programs
|
|---|---|---|
|
Anxiety - STAI-6
|
8.33 units on a scale
Standard Deviation 2.22
|
9.42 units on a scale
Standard Deviation 3.39
|
SECONDARY outcome
Timeframe: Postoperative (within 6 hours after surgery)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.
Outcome measures
| Measure |
Meditation Group
n=15 Participants
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
|
Control Group
n=14 Participants
Standard of care, which does not involve any meditation programs
|
|---|---|---|
|
Interoceptive Attention - MAIA (Noticing Sub Scale)
|
14.3 units on a scale
Standard Deviation 4.46
|
11.5 units on a scale
Standard Deviation 4.92
|
Adverse Events
Meditation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chien Yi Maximilian Png, MD
Massachusetts General Hospital
Phone: 617-726-5308
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place