Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers

Anxiety Clinical Trial

Official title:

Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671628
• Other study ID #: 1690558
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Old Dominion University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Gastrointestinal System--Abnormalities
• Visceral Pain

Intervention

Behavioral:
• Relaxing music
Participants will be asked to listen to relaxing music for 30 minutes each day. They will allowed to choose between several playlists based on their preference.

Locations

Country	Name	City	State
United States	Human Performance Laboratory	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Old Dominion University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gastrointestinal symptom severity	The severity of several gastrointestinal symptoms will be assessed on a validated 0-10 scale.	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
Primary	Change in anxiety levels	Levels of anxiety will be assessed with the General Anxiety Disorder-7 questionnaire. Scores on the General Anxiety Disorder-7 range from 0 to 21, with higher scores indicating higher levels of anxiety.	The intervention will last 2 weeks. The General Anxiety Disorder-7 will be assessed before the intervention begins and again after 2 weeks.
Secondary	Change in visceral sensitivity	Perceptions of visceral sensitivity will be assessed via the Visceral Sensitivity Index. Scores on the Visceral Sensitivity Index can range from 0 to 75, with higher scores indicating a higher level of visceral sensitivity.	The intervention will last 2 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins and again after 2 weeks.
Secondary	Change in perceived stress	Perceived life stress will be evaluated with the Perceived Stress Scale 14. Scores on this scale can range from 0 to 56, will higher scores indicating greater amounts of stress.	The intervention will last 2 weeks. The Perceived Stress Scale 14 will be assessed before the intervention begins and again after 2 weeks.