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NCT05650073 Clinical Trial

A Study of Soundscapes for Patient Wellbeing

Varicose Veins Clinical Trial

Official title:
Impact of Immersive Soundscapes in Outpatient Procedure Rooms on Patient Wellbeing

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05650073
Other study ID # 22-008617
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 16, 2023
Est. completion date June 2024

Study information
Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - English-speaking adults Exclusion Criteria: - Patients needing an English interpreter - Patients who lack the capacity to provide consent.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Immersive soundscapes
Audio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape

Locations
Country Name City State
United States Mayo Clinic Arizona Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Self-Report Visual Analog Pain Score 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). Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Primary Change in Self-Report Visual Analog Anxiety Score 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. Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Primary Change in Self-Report Visual Analog Stress Score 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. Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Primary Change in Heart Rate Number of beats per minute Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Primary Change in Blood Pressure Measured in millimeters of mercury (mmHg) Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
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