NCT04292145

Brief Summary

The study aims to assess the validity of a relaxation app. This will be accomplished by obtaining self-report measures about mood and respiratory symptoms. We hypothesize that self-report in the relaxation app condition will be different from that of the relaxation only condition.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 22, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

February 7, 2020

Last Update Submit

April 23, 2024

Conditions

Keywords

breathebreathingrelaxrelaxationrespirationstress

Outcome Measures

Primary Outcomes (2)

  • Sensations Questionnaire

    Perceived bodily sensations. Scores range from 10-100, where higher scores indicate sensitivity to bodily sensations.

    at study completion, up to 2 years

  • Positive and Negative Affect Schedule

    Immediate experience of mood. The measure consists of two scales, negative and positive items. Scores range from 10-50 for the positive scale, where higher scores indicate greater positive mood, and scores range from 10-50 for the negative scale, where higher scores indicate greater negative mood.

    at study completion, up to 2 years

Study Arms (2)

Relaxation Application

EXPERIMENTAL

Participants will follow the relaxation application.

Behavioral: Relaxation Application

Relaxation Only

ACTIVE COMPARATOR

Participants will use any relaxation technique they normally use to relax.

Behavioral: Relaxation Only

Interventions

The use of an application for relaxation.

Relaxation Application
Relaxation OnlyBEHAVIORAL

The individual's personal method to relax.

Relaxation Only

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Student enrolled in SMU
  • Speaks English

You may not qualify if:

  • Must have an Apple Watch to use during time of participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75206, United States

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalRespiratory Aspiration

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Y Kim, BA

    Southern Methodist University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Y Kim, BA

CONTACT

Alicia E Meuret, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of the purpose of the study, thus they will not know if they are in the experimental or control group.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of the two groups as they enter the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2020

First Posted

March 2, 2020

Study Start

April 22, 2020

Primary Completion

April 22, 2024

Study Completion

December 22, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations