Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-11

Study Completion Date

2024-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

The proceduralists that will be performing the peripheral vascular interventions will be blinded to the group allocation.

Study Groups

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Meditation Group

Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

Guided meditation utilizing breath awareness, body scan and visualization techniques

Control Group

Standard of care, which does not involve any meditation programs

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Meditation

Guided meditation utilizing breath awareness, body scan and visualization techniques

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No