NCT05837481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 11, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 16, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

April 6, 2023

Results QC Date

February 7, 2024

Last Update Submit

October 11, 2024

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately before surgery

Secondary Outcomes (4)

  • Anxiety - STAI-6

    Preoperative (prior to meditation)

  • Interoceptive Attention - MAIA (Noticing Sub Scale)

    Preoperative (prior to meditation)

  • Anxiety - STAI-6

    Postoperative (within 6 hours after surgery)

  • Interoceptive Attention - MAIA (Noticing Sub Scale)

    Postoperative (within 6 hours after surgery)

Study Arms (2)

Meditation Group

EXPERIMENTAL

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

Behavioral: Meditation

Control Group

NO INTERVENTION

Standard of care, which does not involve any meditation programs

Interventions

MeditationBEHAVIORAL

Guided meditation utilizing breath awareness, body scan and visualization techniques

Meditation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Undergoing an endovascular procedure for peripheral vascular disease
  • Anesthesia plan for procedural sedation and analgesia

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Salem Hospital

Salem, Massachusetts, 01970, United States

Location

Southern New Hampshire Hospital

Nashua, New Hampshire, 03060, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Meditation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Chien Yi Maximilian Png, MD
Organization
Massachusetts General Hospital
cypng@mgh.harvard.edu
617-726-5308

Study Officials

  • Chien Yi M Png, MD

    Massachusetts General Hospital

    STUDY CHAIR

  • Chien Yi M Png, MD

    Massachusetts General Hospital

    STUDY DIRECTOR

  • Anahita Dua, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The proceduralists that will be performing the peripheral vascular interventions will be blinded to the group allocation.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 1, 2023

Study Start

July 11, 2023

Primary Completion

December 11, 2023

Study Completion

April 1, 2024

Last Updated

October 16, 2024

Results First Posted

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)