N/A
N=30
Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery
Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT05837481 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Feasibility of Implementing Preoperative Guided Meditation — 15; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Meditation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Implementing Preoperative Guided Meditation |
15; 14 | — |
| SECONDARY Anxiety - STAI-6 |
8.33; 9.42 | — |
| SECONDARY Interoceptive Attention - MAIA (Noticing Sub Scale) |
14.3; 11.5 | — |
| SECONDARY Anxiety - STAI-6 |
8.33; 9.42 | — |
| SECONDARY Interoceptive Attention - MAIA (Noticing Sub Scale) |
14.3; 11.5 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05837481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.