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Soundscapes for Surgery-Related Pain and Anxiety Management
N/A
Waitlist Available
Led By Ellen Meltzer, MD, MS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English-speaking adults
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Awards & highlights
Study Summary
This trial looks at how soundscapes can reduce pain and anxiety in patients during surgery. #PainManagement #AnxietyReduction
Who is the study for?
This trial is for English-speaking adults who are undergoing outpatient vascular surgery for varicose veins. It's not suitable for those who need an interpreter or can't consent.Check my eligibility
What is being tested?
The study is testing whether immersive soundscapes can help reduce pain, stress, anxiety and improve heart rate and blood pressure during the procedure.See study design
What are the potential side effects?
There may be no direct side effects from listening to soundscapes; however, individual reactions to audio stimulation vary and could include discomfort or increased anxiety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult who speaks English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Blood Pressure
Change in Heart Rate
Change in Self-Report Visual Analog Anxiety Score
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immersive Soundscapes EnvironmentExperimental Treatment1 Intervention
Subjects having venous ablation with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure.
Group II: Control EnvironmentActive Control1 Intervention
Subjects having venous ablation with Vascular Surgery at Mayo Clinic will have no music played during the procedure.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,684 Total Patients Enrolled
1 Trials studying Varicose Veins
134 Patients Enrolled for Varicose Veins
Ellen Meltzer, MD, MSPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult who speaks English.I am unable to understand or sign a consent form.I need an English interpreter.
Research Study Groups:
This trial has the following groups:- Group 1: Control Environment
- Group 2: Immersive Soundscapes Environment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to be a participant in this trial?
"100 English-speaking adults between 18 and 100 years old who suffer from varicose veins may enroll in this clinical trial."
Answered by AI
Is the age cap for this research above or below 25 years old?
"This investigation is seeking patients who are above the age of majority but below a century in age."
Answered by AI
Is enrollment for this experiment still accessible to individuals?
"Confirmed. According to clinicaltrials.gov, this particular medical study is not actively recruiting patients at the time of writing; it was first posted on January 1st 2023 and last edited on December 6th 2022. Fortunately, there are 28 other trials that have open participant recruitment right now."
Answered by AI
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