A Study of Soundscapes for Patient Wellbeing

NCT ID: NCT05650073

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2025-07-15

Brief Summary

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The purpose of this study is to assess the impact of immersive soundscape on patient pain, stress, anxiety, heart rate and blood pressure during an outpatient vascular surgery procedure.

Detailed Description

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Adult (≥18-years-old) patients having outpatient vascular surgery procedures who elect to participate in the study will be randomized to Control/ Intervention. For Control Subjects: procedure will be performed in the procedure room with no immersive soundscape. For Intervention Subjects procedure will be performed in the procedure room with immersive soundscape.

Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Immersive Soundscapes Environment

Subjects having venous ablation OR port removal with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure.

Group Type EXPERIMENTAL

Immersive soundscapes

Intervention Type OTHER

Audio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape

Control Environment

Subjects having venous ablation OR port removal with Vascular Surgery at Mayo Clinic will have no music played during the procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Immersive soundscapes

Audio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- English-speaking adults

Exclusion Criteria

* Patients needing an English interpreter
* Patients who lack the capacity to provide consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ellen C. Meltzer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen Meltzer, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status

Countries

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United States

Related Links

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https://www.mayoclinic.org

Mayo Clinic Clinical Trials

Other Identifiers

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22-008617

Identifier Type: -

Identifier Source: org_study_id

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