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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Visceral Pain; Gastrointestinal System--Abnormalities
• Intervention / Treatment: Behavioral: Relaxing music

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Wilson; Phone Number: 7576834783; Email: pbwilson@odu.edu

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23529
      • Human Performance Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Relaxing music	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Old Dominion University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Nociceptive Pain; Anxiety Disorders; Visceral Pain
• Other Study ID Numbers: 1690558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No