A Study of Soundscapes for Patient Wellbeing

Not Applicable

• Conditions: Varicose Veins
• Interventions: Other: Immersive soundscapes

• Registration Number: NCT05650073
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-14
• Study Start: 2023-06-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• English-speaking adults

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immersive Soundscapes Environment	Immersive soundscapes	Subjects having venous ablation OR port removal with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure.

Primary Outcome Measures

Name	Time	Method
Change in Heart Rate	Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour	Number of beats per minute
Change in Self-Report Visual Analog Pain Score	Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour	Using a ruler, patients select a pain score from 0, "no pain" to 100 "intolerable pain", with a higher score indicating greater pain. The distance between "0/ no pain" and the mark indicates the pain level. The following cut points for quantifying pain using a VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Change in Self-Report Visual Analog Anxiety Score	Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour	Using a ruler, patients select an anxiety score from 0, "no anxiety" to 100 "maximum anxiety imaginable", with a higher score indicating greater anxiety. The distance between "0/ no anxiety" and the mark indicates the anxiety level. Visual analogue scale for anxiety (VAS-A) has demonstrated to be a useful tool for measuring preoperative anxiety with a threshold for a clinically relevant level of anxiety at around 50mm.
Change in Self-Report Visual Analog Stress Score	Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour	Using a ruler, patients select an anxiety score from 0, "no stress" to 100 "maximum anxiety imaginable", with a higher score indicating greater anxiety. The distance between "0/ no anxiety" and the mark indicates the anxiety level. Visual analogue scale for anxiety (VAS-A) has demonstrated to be a useful tool for measuring preoperative anxiety with a threshold for a clinically relevant level of anxiety at around 50mm.
Change in Blood Pressure	Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour	Measured in millimeters of mercury (mmHg)

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States