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Clinical Trials/NCT04671628
NCT04671628
Completed
Not Applicable

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

Old Dominion University1 site in 1 country19 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal System--Abnormalities
Sponsor
Old Dominion University
Enrollment
19
Locations
1
Primary Endpoint
Change in anxiety levels
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
October 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrick Wilson, PhD

Associate Professor of Exercise Science

Old Dominion University

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

Outcomes

Primary Outcomes

Change in anxiety levels

Time Frame: 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

Time Frame: 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 Outcomes

  • 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.)
  • 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.)

Study Sites (1)

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