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NCT Number: NCT05837481

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

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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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Meditation

Behavioral

Guided meditation utilizing breath awareness, body scan and visualization techniques

Primary outcomes

  1. Feasibility of Implementing Preoperative Guided Meditation

    Time frame: 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 outcomes

  1. Anxiety - STAI-6

    Time frame: 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.

  2. Interoceptive Attention - MAIA (Noticing Sub Scale)

    Time frame: 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.

  3. Anxiety - STAI-6

    Time frame: 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.

  4. Interoceptive Attention - MAIA (Noticing Sub Scale)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 1, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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