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

Primary Purpose

Gastrointestinal System--Abnormalities, Anxiety, Visceral Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxing music
Sponsored by
Old Dominion University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal System--Abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Human Performance LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Relaxing music

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 8, 2020
Last Updated
September 19, 2022
Sponsor
Old Dominion University
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1. Study Identification

Unique Protocol Identification Number
NCT04671628
Brief Title
Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers
Official Title
Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Old Dominion University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal System--Abnormalities, Anxiety, Visceral Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relaxing music
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Relaxing music
Intervention Description
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 Outcome Measure Information:
Title
Change in gastrointestinal symptom severity
Description
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
Title
Change in anxiety levels
Description
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 Outcome Measure Information:
Title
Change in visceral sensitivity
Description
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.
Title
Change in perceived stress
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Wilson
Phone
7576834783
Email
pbwilson@odu.edu
Facility Information:
Facility Name
Human Performance Laboratory
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23529
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Wilson
Phone
757-683-4783
Email
pbwilson@odu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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