Clinical trial NCT04671628: Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers
Official title: Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal System--Abnormalities
Anxiety
Visceral Pain
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the impacts of a 2-week relaxing music intervention on stress, anxiety, and gut symptoms in individuals who regularly perform structured aerobic exercise. Gut symptoms like bloating, reflux, cramping, nausea, etc. are relatively common during prolonged aerobic exercise. In addition, previous research has established that levels of anxiety and stress are associated with a higher occurrence of these gut symptoms. Relaxing music has reduced anxiety in certain populations, but currently, no studies are available on its effects on anxiety, stress, and gut symptoms in people who regularly do aerobic exercise.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* do 120+ minutes per week of planned/structured aerobic exercise of at least moderate intensity
* have had at least mild anxiety over the past 2 weeks (GAD-7 score of 5 or more)
* not currently on a psychotropic medication, or if they are on one, they must have been on a stable dose for the past three months
* not currently listening to music for relaxation purposes regularly (\>60 minutes per week)
* have at least sometimes experienced gut symptoms (nausea, gas, bloating, cramping, side stitching, urge to defecate, etc.) during aerobic exercise sessions over the last month
* have access to the internet

Exclusion Criteria:

* not at least 18 years of age
* don't do 120+ minutes per week of planned/structured aerobic exercise of at least moderate intensity
* haven't had at least mild anxiety over the past 2 weeks (GAD-7 score of 5 or more)
* have recently started taking a psychotropic medication (within past 3 months)
* currently listening to music for relaxation purposes regularly (\>60 minutes per week)
* have never or rarely experienced gut symptoms (nausea, gas, bloating, cramping, side stitching, urge to defecate, etc.) during aerobic exercise sessions over the last month
* don't have internet access

Primary outcomes:
measure: Change in gastrointestinal symptom severity
timeFrame: The intervention will last 2 weeks. Gastrointestinal symptoms will be collected for a 1-week period before the intervention and during the 2nd week of the intervention
measure: Change in anxiety levels
timeFrame: The intervention will last 2 weeks. The General Anxiety Disorder-7 will be assessed before the intervention begins and again after 2 weeks.
Secondary outcomes:
measure: Change in visceral sensitivity
timeFrame: The intervention will last 2 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins and again after 2 weeks.
measure: Change in perceived stress
timeFrame: The intervention will last 2 weeks. The Perceived Stress Scale 14 will be assessed before the intervention begins and again after 2 weeks.
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Human Performance Laboratory
state: Virginia
Study officials:
References: