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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the intervention will last 2 weeks. the perceived stress scale 14 will be assessed before the intervention begins and again after 2 weeks.
Awards & highlights
Study Summary
This trial will study the effects of relaxing music on stress, anxiety, and gut symptoms in people who regularly do aerobic exercise.
Eligible Conditions
- Anxiety
- Visceral Pain
- Gastrointestinal Abnormalities
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the intervention will last 2 weeks. the visceral sensitivity index will be assessed before the intervention begins and again after 2 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the intervention will last 2 weeks. the visceral sensitivity index will be assessed before the intervention begins and again after 2 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Change in gastrointestinal symptom severity
Secondary outcome measures
Change in perceived stress
Change in visceral sensitivity
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Relaxing musicExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relaxing music
2021
N/A
~20
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Who is running the clinical trial?
Old Dominion UniversityLead Sponsor
20 Previous Clinical Trials
15,025 Total Patients Enrolled
1 Trials studying Anxiety
63 Patients Enrolled for Anxiety
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You don't exercise for more than 2 hours per week with moderate to high intensity.You rarely or have not experienced stomach discomfort, such as feeling sick, bloating, or cramping, during exercise in the past month.You listen to music regularly for relaxation purposes for more than an hour each week.You cannot access the internet.You started taking a medication for mental health issues within the last three months.You do not listen to music regularly for relaxation purposes for more than an hour per week.You have had stomach problems (like feeling sick, bloating, or cramping) at least once during exercise in the past month.You have been feeling anxious for at least the past 2 weeks, as measured by a score of 5 or more on a questionnaire called the GAD-7.You should exercise for at least 2 hours per week with planned and structured aerobic exercises of moderate intensity.You have experienced some level of anxiety in the past two weeks, as measured by a questionnaire called GAD-7.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Relaxing music
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.
How many participants are being welcomed into this clinical research endeavor?
"Indeed, clinicaltrials.gov confirms that this medical trial is still recruiting participants who signed up since its inception on January 1st 2021. 40 patients need to be sourced from a single centre for the study."
Answered by AI
What is the current enrollment status for this research project?
"Clinicaltrials.gov data confirms that this trial, posted initially on January 1st 2021, is actively looking for participants with the most recent update occurring September 19th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
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