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

Not Applicable

Completed

• Conditions: Visceral Pain; Anxiety; Gastrointestinal System--Abnormalities
• Interventions: Behavioral: Relaxing music

• Registration Number: NCT04671628
• Lead Sponsor: Old Dominion University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-17
• Study Start: 2021-01-01
• Status Verified: 2023-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxing music	Relaxing music	-

Primary Outcome Measures

Name	Time	Method
Change in anxiety levels	The intervention will last 2 weeks. The General Anxiety Disorder-7 will be assessed before the intervention begins and again after 2 weeks.	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.
Change in gastrointestinal symptom severity	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	The severity of several gastrointestinal symptoms will be assessed on a validated 0-10 scale.

Secondary Outcome Measures

Name	Time	Method
Change in visceral sensitivity	The intervention will last 2 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins and again after 2 weeks.	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.
Change in perceived stress	The intervention will last 2 weeks. The Perceived Stress Scale 14 will be assessed before the intervention begins and again after 2 weeks.	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.

Trial Locations

Locations (1)

Human Performance Laboratory; 🇺🇸 Norfolk, Virginia, United States