Peripheral Vascular DiseaseNCT05837481
Guided Meditation to Decrease Perioperative Anxiety and Increase Patient Intraoperative Compliance in Vascular Surgery
A study testing Meditation in people with Peripheral Vascular Disease, run by Massachusetts General Hospital at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jul 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Undergoing an endovascular procedure for peripheral vascular disease
- Anesthesia plan for procedural sedation and analgesia
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Southern New Hampshire Hospital
Nashua, New Hampshire, 03060
Newton Wellesley Hospital
Newton, Massachusetts, 02462
Salem Hospital
Salem, Massachusetts, 01970
About this study
Official title: Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation
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.
Read the detailed description
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
- Peripheral Vascular Disease
- Being tested
- Meditation
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Guided meditation utilizing breath awareness, body scan and visualization techniques
| Study group | Role | What they receive |
|---|---|---|
| Meditation Group | Experimental | Two sessions of guided meditation on the day of surgery, both to occur before the start of surgery Receives: Behavioral: Meditation |
| Control Group | No intervention | Standard of care, which does not involve any meditation programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before surgery
Secondary outcomes (4)
Anxiety - STAI-6
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.
Measured: Preoperative (prior to meditation)
Interoceptive Attention - MAIA (Noticing Sub Scale)
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.
Measured: Preoperative (prior to meditation)
Anxiety - STAI-6
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.
Measured: Postoperative (within 6 hours after surgery)
Interoceptive Attention - MAIA (Noticing Sub Scale)
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.
Measured: Postoperative (within 6 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start11 Jul 2023
- Primary completion11 Dec 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Anahita Dua, MBCHB, MBA, MSC, Massachusetts General Hospital
- Investigators
- Chien Yi M Png, MD, Study chair, Massachusetts General HospitalChien Yi M Png, MD, Study director, Massachusetts General HospitalAnahita Dua, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837481
- Sponsor's protocol ID
- 2021P002072
- Other IDs
- F32HS028943-01
- Status last verified
- Oct 2024
- First submitted
- 6 Apr 2023
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation
- ClinicalTrials.gov ID
- NCT05837481
- Acronym / sponsor ID
- 2021P002072
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Group | Experimental | Behavioral: MeditationTwo sessions of guided meditation on the day of surgery, both to occur before the start of surgery |
| Control Group | No intervention | –Standard of care, which does not involve any meditation programs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Undergoing an endovascular procedure for peripheral vascular disease
- Anesthesia plan for procedural sedation and analgesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationGuided meditation utilizing breath awareness, body scan and visualization techniques | Behavioural | Meditation Group |
Primary outcome
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.
4 secondary outcomes
Anxiety - STAI-6
Time frame: Preoperative (prior to meditation)
Interoceptive Attention - MAIA (Noticing Sub Scale)
Time frame: Preoperative (prior to meditation)
Anxiety - STAI-6
Time frame: Postoperative (within 6 hours after surgery)
Interoceptive Attention - MAIA (Noticing Sub Scale)
Time frame: Postoperative (within 6 hours after surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien Yi M Png, MD study chair
Massachusetts General Hospital
Chien Yi M Png, MD study director
Massachusetts General Hospital
Anahita Dua, MD principal investigator
Massachusetts General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Peripheral Vascular Disease, run by Massachusetts General Hospital at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Implementing Preoperative Guided Meditation (time frame: Immediately before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.