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Therapeutic Music Sessions for Critical Illness
N/A
Waitlist Available
Led By Joseph J. Schlesinger
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient
Be older than 18 years old
Must not have
Patient Exclusion Criteria: Airborne or special contact isolation, Unstable hypotension or bradycardia, Pregnancy, Current prisoner status, The inability to communicate either verbally or in writing in English to complete the therapeutic music evaluations, Refusal to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after conclusion of therapeutic music session (about 20 minutes)
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of music on patients in the ICU, their families, and staff.
Who is the study for?
This trial is for adult ICU patients at Vanderbilt University Medical Center, their family members, and ICU staff present during music sessions. Excluded are those with certain isolation precautions, unstable vital signs, pregnant women, prisoners, or anyone unable to communicate in English.
What is being tested?
The study aims to assess the impact of live therapeutic music sessions on relaxation and pain relief among critically ill patients in the ICU as well as its effects on their families and medical staff.
What are the potential side effects?
Since this intervention involves live music sessions rather than medication or invasive procedures, there are no direct physical side effects expected from participating in this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a patient seeking treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, imprisoned, or in isolation. My blood pressure and heart rate are stable. I can communicate in English and am willing to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after conclusion of therapeutic music session (about 20 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after conclusion of therapeutic music session (about 20 minutes)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in perceived anxiety visual analog score
Change in perceived pain visual analog score
Change in perceived relaxation visual analog scale
Secondary study objectives
Acceptability of Intervention Measure (AIM)
Feasibility of Intervention (FIM)
Intervention Appropriateness Measure (IAM)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Therapeutic Music SessionExperimental Treatment1 Intervention
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
903 Previous Clinical Trials
938,276 Total Patients Enrolled
13 Trials studying Critical Illness
4,920 Patients Enrolled for Critical Illness
Joseph J. SchlesingerPrincipal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, imprisoned, or in isolation. My blood pressure and heart rate are stable. I can communicate in English and am willing to participate.My family member cannot communicate in English or refuses to participate.I am a patient seeking treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Therapeutic Music Session
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.
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