A Study of Soundscapes for Patient Wellbeing

Mayo Clinic

Status: Invitation-only

Conditions: Varicose Veins

Treatments: Other: Immersive soundscapes

Study type: Interventional

Funder types: Other

Identifiers

NCT05650073

22-008617

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English-speaking adults

Exclusion criteria

• Patients needing an English interpreter
• Patients who lack the capacity to provide consent.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Immersive Soundscapes Environment

Experimental group

Description:

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

Treatment:

Other: Immersive soundscapes

Control Environment

No Intervention group

Description:

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