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Completed

NCT Number: NCT04671628

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.

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Key information

Conditions

Gastrointestinal System--Abnormalities Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Visceral Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Performance Laboratory

Norfolk, Virginia, 23529, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxing music

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in visceral sensitivity

    Time frame: 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.

  2. Change in perceived stress

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Old Dominion University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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