ClinicalTrials.gg
CompletedNCT04671628Updated Nov 1, 2023

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

An interventional study of Relaxing music in Gastrointestinal System--Abnormalities, Anxiety and Visceral Pain, sponsored by Old Dominion University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.

Primary conditionVisceral PainRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Visceral Pain
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Visceral Pain.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Old Dominion University · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Visceral Pain with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Visceral Pain · United States.

Enrollment
12th of 14
19 · median 89
Started
2021
with 1 other
No phase
11 of 16
4 open now
Registered
12th of 16
by date
Lead sponsor
2 of 16
Old Dominion University

Among the 16 studies in Visceral Pain with a site in United States, this one is the 12th largest by enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2021, is one of 11 with no phase, and was the 12th registered.

Visceral Pain

55 studies on the registry are indexed under Visceral Pain; 19 are open to participants now.

Browse Visceral Pain studies →

Open to participants now

4 of the 16 studies in Visceral Pain with a site in United States are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 8 Visceral Pain studies recruiting now, 1 sets no upper age limit and 5 stop at 75 or younger; none take children under 18; 3 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Visceral Pain with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Gastrointestinal System--Abnormalities
  • Anxiety
  • Visceral Pain

Browse trials for

04

In context

Visceral Pain Reclassified

55 studies on the registry are indexed under Visceral Pain; 19 are open to participants now.

This study's enrollment of 19 is below the median of 72 across 47 interventional studies indexed under Visceral Pain.

Browse Visceral Pain studies →

Lead sponsor

Old Dominion University is the lead sponsor of 27 studies on the registry; 4 are open to participants now.

Compared within Visceral Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Relaxing music

    Behavioral: Relaxing music

  • No intervention
    Control

Interventions

  • BehavioralRelaxing 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.

07

What researchers measure

Primary outcomes

  1. Change in gastrointestinal symptom severity

    The severity of several gastrointestinal symptoms will be assessed on a validated 0-10 scale.

    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

  2. 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.

    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.

Secondary outcomes

  1. 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.

    Time frame: The intervention will last 2 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins and again after 2 weeks.

  2. 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.

    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.

08

Study locations

1 site
  • Human Performance Laboratory
    Norfolk, Virginia 23529, United States
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2021 to primary completion in Oct 2023, 33 months.

Of 16 interventional studies with no phase under Visceral Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 33. This study's 33 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2020
First posted
Dec 17, 2020
StartActual
Jan 1, 2021
Primary completionActual
Oct 1, 2023
CompletionActual
Oct 1, 2023
Last update
Nov 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04671628
Lead sponsor
Old Dominion University
Responsible party
Patrick Wilson, PhD (Associate Professor of Exercise Science, Old Dominion University) — Principal investigator
First posted
Dec 17, 2020
Start date
Jan 1, 2021
Primary completion
Oct 1, 2023
Completion
Oct 1, 2023
Last update
Nov 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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